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Low Dose Aspirin for Venous Leg Ulcers (Aspirin4VLU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02158806
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
Health Research Council, New Zealand
Information provided by (Responsible Party):
Andrew Jull, University of Auckland, New Zealand

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Venous Leg Ulcer
Interventions Drug: Aspirin
Drug: Placebo
Enrollment 251
Recruitment Details Participants were screened and recruited from five study sites in New Zealand
Pre-assignment Details Enrolled participants were required to have their family physician confirm they could safely participate in the trial ie had no conditions that required treatment with aspirin and no conditions that contraindicated use of aspirin.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Period Title: Overall Study
Started 125 126
Completed 121 [1] 121 [1]
Not Completed 4 5
Reason Not Completed
Death             2             0
Withdrawal by Subject             2             0
Lost to Follow-up             0             3
Moved out of area             0             1
Transferred to palliative care             0             1
[1]
We had information on all participants for the primary outcome (time to complete healing).
Arm/Group Title Aspirin Placebo Total
Hide Arm/Group Description

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Total of all reporting groups
Overall Number of Baseline Participants 125 126 251
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 126 participants 251 participants
60.1  (17.1) 56.2  (16.1) 58.2  (16.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Female
60
  48.0%
58
  46.0%
118
  47.0%
Male
65
  52.0%
68
  54.0%
133
  53.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Māori
21
  16.8%
16
  12.7%
37
  14.7%
Pasifika
23
  18.4%
30
  23.8%
53
  21.1%
Asian
4
   3.2%
5
   4.0%
9
   3.6%
NZ European/Pākehā
77
  61.6%
74
  58.7%
151
  60.2%
Other
0
   0.0%
1
   0.8%
1
   0.4%
Highest educational attainment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Primary school
9
   7.2%
6
   4.8%
15
   6.0%
Secondary school
66
  52.8%
74
  58.7%
140
  55.8%
Undergraduate
9
   7.2%
17
  13.5%
26
  10.4%
Postgraduate
21
  16.8%
11
   8.7%
32
  12.7%
Vocational/technical
20
  16.0%
17
  13.5%
37
  14.7%
None
0
   0.0%
1
   0.8%
1
   0.4%
Smoking status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Never smoked
62
  49.6%
63
  50.0%
125
  49.8%
Former smoker
47
  37.6%
44
  34.9%
91
  36.3%
Current smoker
16
  12.8%
19
  15.1%
35
  13.9%
Medical history  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
Diabetes
13
  10.4%
13
  10.3%
26
  10.4%
Prior DVT
11
   8.8%
7
   5.6%
18
   7.2%
Lower limb joint replacement
16
  12.8%
19
  15.1%
35
  13.9%
Prior lower limb fracture
18
  14.4%
23
  18.3%
41
  16.3%
Prior treatment for varicosities
35
  28.0%
33
  26.2%
68
  27.1%
Ankle Brachial Index  
Mean (Standard Deviation)
Unit of measure:  Ratio of SBP ankle/SBP arm
Number Analyzed 125 participants 126 participants 251 participants
1.1  (0.1) 1.1  (0.1) 1.1  (0.1)
Reference ulcer area  
Median (Inter-Quartile Range)
Unit of measure:  Square centimetres
Number Analyzed 125 participants 126 participants 251 participants
2.6
(0.9 to 6.8)
2.3
(0.9 to 6.1)
2.5
(0.9 to 6.3)
Compression system  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 126 participants 251 participants
High compression
105
  84.0%
102
  81.0%
207
  82.5%
Light compression
11
   8.8%
11
   8.7%
22
   8.8%
Hosiery
8
   6.4%
13
  10.3%
21
   8.4%
Other
1
   0.8%
0
   0.0%
1
   0.4%
1.Primary Outcome
Title Time to Complete Healing of Reference Ulcer
Hide Description Time to event (complete healing defined as intact skin with absence of scab)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 125 126
Median (95% Confidence Interval)
Unit of Measure: days
77
(56 to 98)
69
(56 to 98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Placebo group = reference group
Type of Statistical Test Superiority
Comments Participants analysed in the groups to which they were randomised (intention to treat analysis).
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.64 to 1.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.146
Estimation Comments Placebo group = reference group
2.Secondary Outcome
Title Number of Participants With Healed Venous Leg Ulcers
Hide Description Number of participants in each arm with completely healed reference ulcers at 24 weeks
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
88
  70.4%
101
  80.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Participants analysed in the groups to which they were randomised (intention to treat analysis).
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.76 to 1.01
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Estimated Ulcer Area
Hide Description Change in estimated ulcer area from baseline to 24 weeks
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Ulcer area estimated using maximum width and length of the ulcer to calculate the area of an ellipse. We have previously shown this approach to be highly correlated with digital calculation of measured area (r=0.92).
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 125 126
Mean (Standard Error)
Unit of Measure: square centimetres
4.1  (0.4) 4.8  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments Adjusted for baseline values.
Method ANCOVA
Comments One participant in aspirin group had missing data for 24 week endpoint visit; we used the baseline value for imputation.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.7
Confidence Interval (2-Sided) 95%
-1.9 to 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.6
Estimation Comments Placebo group = reference group.
4.Secondary Outcome
Title Change in Health-related Quality of Life (Short Form 36)
Hide Description Mean difference in change in Short Form 36 (SF36) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomized.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 116 115
Mean (Standard Error)
Unit of Measure: units on a scale
Physical Functioning 5.0  (2.2) 3.8  (2.2)
Role Physical 11.7  (3.4) 10.3  (3.4)
Bodily Pain 11.4  (2.2) 9.0  (2.2)
General Health -1.1  (1.4) -0.8  (1.4)
Vitality 3.9  (1.6) -0.3  (1.6)
Social Functioning 5.8  (2.2) 4.9  (2.2)
Role Emotional 10.5  (3.1) 6.8  (3.1)
Mental Health -1.2  (1.4) 1.2  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Physical Functioning
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.714
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
-5.0 to 7.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Role Physical
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.768
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-8.0 to 10.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Bodily Pain
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.449
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-3.7 to 8.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in General Health
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.873
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-4.3 to 3.6
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Vitality
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.2
Confidence Interval (2-Sided) 95%
-0.1 to 8.5
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Social Functioning
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.756
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-5.1 to 7.0
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Role Emotional
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.400
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.7
Confidence Interval (2-Sided) 95%
-4.9 to 12.3
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in Mental Health
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.236
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-6.2 to 1.5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Health-related Quality of Life (EuroQol-5D 3L)
Hide Description Mean difference in change measured by EuroQol 5D (EQ5D 3L) from baseline to 24 weeks. Crude health state scores for each group are not shown (health state is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on health state for that group.
Time Frame Baseline, 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 116 115
Mean (Standard Error)
Unit of Measure: score on a scale
7.4  (1.6) 4.0  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.156
Comments Adjusted for baseline values
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
-1.3 to 8.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Health-related Quality of Life (Charing Cross Venous Ulcer Questionnaire)
Hide Description Mean difference in change in Charing Cross Venous Ulcer Questionnaire (CXVUQ)) from baseline to 24 weeks. Crude subscale scores for each group are not shown (each crude subscale is scored 0 to 100 at baseline and 24 weeks); higher mean differences in change from baseline to 24 weeks within groups indicate greater change on the subscales for that group.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that provided both baseline and endpoint data were included in the analysis. Hence the number of participants included in this analysis is less than the number randomised.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 115 116
Mean (Standard Error)
Unit of Measure: score on a scale
Social function -6.2  (1.3) -4.7  (1.3)
Domestic activities -6.6  (1.1) -5.2  (1.2)
Cosmesis -6.1  (1.6) -4.9  (1.6)
Emotional status -9.4  (1.8) -6.5  (1.8)
Overall -7.3  (1.2) -5.5  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in social function
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.438
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-5.2 to 2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in domestic activities
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.408
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-4.5 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in cosmesis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.568
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-5.6 to 3.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments Change in emotional status
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.257
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-8.1 to 2.2
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.273
Comments [Not Specified]
Method Regression, Linear
Comments Adjusted for baseline values
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-5.2 to 1.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Adherence to Treatment
Hide Description Adherence to study medication as measured by pill counts (agreement between expected number of tablets remaining after healing and days to healing)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 125 126
Measure Type: Count of Participants
Unit of Measure: Participants
92
  73.6%
92
  73.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.917
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.87 to 1.17
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Incidence of Adverse Events at 24 Weeks
Hide Description Total number of different types of adverse events in participants who reported with any untoward medical event
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only participants that reported any reported untoward medical event were included in this analysis.
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description:

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

Overall Number of Participants Analyzed 29 27
Overall Number of Units Analyzed
Type of Units Analyzed: Number of events
40 37
Count of Units
Unit of Measure: Number of events
Cancer 6 1
Cardiovascular 0 4
Gastrointestinal 8 4
Respiratory 3 0
Genitourinary 2 0
Skin & cutaneous 1 5
Accidental injury 4 4
Psychiatric 1 0
Signs & symptoms 7 5
Leg ulcer bleeding 2 2
Leg ulcer infection 2 4
Extension of leg ulcer 1 2
New leg ulcer 1 3
Other 2 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aspirin, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method IRR test statistic
Comments Incidence Rate Ratio (IRR) test statistic compared to probability of the same obtained from standard normal distribution tables.
Method of Estimation Estimation Parameter Incidence Rate Ratio
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.7 to 1.7
Estimation Comments [Not Specified]
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aspirin Placebo
Hide Arm/Group Description

150 mg capsule once daily for up to 24 weeks

Aspirin: 150 mg aspirin in capsule form once daily for up to 24 weeks

Matching inert capsule once daily for up to 24 weeks

Placebo: Matching placebo capsule containing inert bulking agent

All-Cause Mortality
Aspirin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/125 (1.60%)      0/126 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/125 (8.80%)      10/126 (7.94%)    
Blood and lymphatic system disorders     
Hospitalisation or prolongation of hospitalisation  1 [1]  0/125 (0.00%)  0 1/126 (0.79%)  1
Hospitalisation or prolongation of hospitalisation  1 [2]  1/125 (0.80%)  1 0/126 (0.00%)  0
Cardiac disorders     
Hospitalisation or prolongation of hospitalisation  1 [3]  0/125 (0.00%)  0 1/126 (0.79%)  1
Hospitalisation or prolongation of hospitalisation  1 [4]  1/125 (0.80%)  1 0/126 (0.00%)  0
Hospitalisation or prolongation of hospitalisation  1 [5]  0/125 (0.00%)  0 1/126 (0.79%)  1
Gastrointestinal disorders     
Hospitalisation or prolongation of hospitalisation  1 [6]  1/125 (0.80%)  1 0/126 (0.00%)  0
Hospitalisation or prolongation of hospitalisation  1 [7]  1/125 (0.80%)  1 0/126 (0.00%)  0
Hospitalisation or prolongation of hospitalisation  1 [8]  0/125 (0.00%)  0 1/126 (0.79%)  1
Hospitalisation or prolongation of hospitalisation  1 [9]  1/125 (0.80%)  1 1/126 (0.79%)  1
Hospitalisation or prolongation of hospitalisation  1 [10]  0/125 (0.00%)  0 1/126 (0.79%)  1
Hospitalisation or prolongation of hospitalisation  1 [11]  1/125 (0.80%)  1 0/126 (0.00%)  0
General disorders     
Hospitalisation or prolongation of hospitalisation  1 [12]  1/125 (0.80%)  2 0/126 (0.00%)  0
Immune system disorders     
Significant medical event  1 [13]  0/125 (0.00%)  0 1/126 (0.79%)  1
Infections and infestations     
Hospitalisation or prolongation of hospitalisation  1 [14]  0/125 (0.00%)  0 1/126 (0.79%)  1
Hospitalisation or prolongation of hospitalisation  2 [15]  1/125 (0.80%)  1 0/126 (0.00%)  0
Hospitalisation or prolongation of hospitalisation  1 [16]  1/125 (0.80%)  1 3/126 (2.38%)  3
Injury, poisoning and procedural complications     
Hospitalisation or prolongation of hospitalisation  1 [17]  0/125 (0.00%)  0 1/126 (0.79%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Hospitalisation or prolongation of hospitalisation  1 [18]  1/125 (0.80%)  2 0/126 (0.00%)  0
Life threatening event of illness  1 [19]  0/125 (0.00%)  0 1/126 (0.79%)  1
Significan medical event  1 [20]  2/125 (1.60%)  2 0/126 (0.00%)  0
Death  1 [21]  1/125 (0.80%)  1 0/126 (0.00%)  0
Renal and urinary disorders     
Hospitalisation or prolongation of hospitalisation  1 [22]  1/125 (0.80%)  1 0/126 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hospitalisation or prolongation of hospitalisation  1 [23]  1/125 (0.80%)  1 0/126 (0.00%)  0
Death  1 [24]  1/125 (0.80%)  1 0/126 (0.00%)  0
Surgical and medical procedures     
Hospitalisation or prolongation of hospitalisation  1 [25]  1/125 (0.80%)  1 0/126 (0.00%)  0
1
Term from vocabulary, ICD-10 AM
2
Term from vocabulary, Study specific code
Indicates events were collected by systematic assessment
[1]
Phlebitis and thrombophlebitis of other deep vessels of lower extremities
[2]
Epistaxis
[3]
Other cardiomyopathies
[4]
Chest pain, unspecified
[5]
Syncope and collapse
[6]
Volvulus
[7]
Constipation
[8]
Haemorrhage of anus and rectum
[9]
Gastrointestinal haemorrhage, unspecified
[10]
Pharyngeal pouch
[11]
Other and unspecified abdominal pain
[12]
Malaise and fatigue
[13]
Allergy, unspecified
[14]
Staphylococcal infection, unspecified site
[15]
Infection of ulceration
[16]
Cellulitis of lower limb
[17]
Fracture shaft of tibia with fracture of fibula (any part)
[18]
Metastatic squamous cell carcinoma
[19]
Malignant neoplasm of brain, unspecified
[20]
Malignant neoplasm of breast, unspecified part
[21]
Malignant neoplasm of prostate
[22]
Acute kidney failure, unspecified
[23]
Pneumonitis due to food and vomit
[24]
Other unspecified respiratory disorder
[25]
Presence of hip implant
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aspirin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/125 (16.00%)      18/126 (14.29%)    
Blood and lymphatic system disorders     
Bleeding from any lower leg ulceration  2  2/125 (1.60%)  2 2/126 (1.59%)  2
Coagulation defect, unspecified  1 [1]  1/125 (0.80%)  1 0/126 (0.00%)  0
Epistaxis  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Gastrointestinal disorders     
Gastro-oesophageal reflux disease without oesophagi's  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Gastric ulcer, unspecified as acute or chronic, without haemorrhage or perforation  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Gastritis, unspecified  1  2/125 (1.60%)  2 1/126 (0.79%)  1
Dyspepsia  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Functional diarrhoea  1  0/125 (0.00%)  0 1/126 (0.79%)  1
Nausea and vomiting  1  2/125 (1.60%)  2 1/126 (0.79%)  1
General disorders     
Hyperhidrosis  1  0/125 (0.00%)  0 1/126 (0.79%)  1
Immune system disorders     
Allergy, unspecified  1  0/125 (0.00%)  0 1/126 (0.79%)  1
Infections and infestations     
Infection of ulceration, any lower leg ulceration  2  1/125 (0.80%)  1 3/126 (2.38%)  4
Candidal stomatitis  1  0/125 (0.00%)  0 1/126 (0.79%)  1
Injury, poisoning and procedural complications     
Tendency to fall, not elsewhere classified  1  0/125 (0.00%)  0 1/126 (0.79%)  1
Laceration and contusions  1  4/125 (3.20%)  4 1/126 (0.79%)  1
Psychiatric disorders     
Depressive episode, unspecified  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Renal and urinary disorders     
Urinary tract infection, site not specified  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory tract infection  1 [2]  1/125 (0.80%)  1 0/126 (0.00%)  0
Skin and subcutaneous tissue disorders     
Developed any new lower leg ulceration  2  1/125 (0.80%)  1 3/126 (2.38%)  3
Extension of reference ulceration  2 [3]  1/125 (0.80%)  1 2/126 (1.59%)  2
Acute inflammation of orbit  1  1/125 (0.80%)  1 0/126 (0.00%)  0
Varicose veins of lower extremities with inflammation  1  0/125 (0.00%)  0 1/126 (0.79%)  1
Cellulitis of lower limb  1  0/125 (0.00%)  0 2/126 (1.59%)  2
Vascular disorders     
Varicose veins of lower extremities without ulcer or inflammation  1 [4]  0/125 (0.00%)  0 1/126 (0.79%)  1
1
Term from vocabulary, ICD-10 AM
2
Term from vocabulary, Study specific code
Indicates events were collected by systematic assessment
[1]
Longer bleeding time on small cuts to hands
[2]
Other specified respiratory disorders
[3]
Including incorporation of other ulcers into reference ulcer
[4]
Saphenous femoral junction incompetence, other leg
Recruitment was lower than anticipated as fewer aspirin-naive patients being available than estimated. However we had 82% power to observe the anticipated difference if assumptions had been correct.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Andrew Jull
Organization: University of Auckland
Phone: +64 9 923 4259
EMail: a.jull@auckland.ac.nz
Layout table for additonal information
Responsible Party: Andrew Jull, University of Auckland, New Zealand
ClinicalTrials.gov Identifier: NCT02158806     History of Changes
Other Study ID Numbers: Aspirin4VLU
First Submitted: June 5, 2014
First Posted: June 9, 2014
Results First Submitted: November 14, 2018
Results First Posted: January 4, 2019
Last Update Posted: January 4, 2019