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Trial record 42 of 507 for:    ASPIRIN AND P2

Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR (TI-PAD EVR)

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ClinicalTrials.gov Identifier: NCT02227368
Recruitment Status : Terminated
First Posted : August 28, 2014
Results First Posted : June 14, 2017
Last Update Posted : July 19, 2017
Sponsor:
Collaborator:
CPC Clinical Research
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Peripheral Artery Disease (PAD)
Interventions Drug: Ticagrelor
Drug: Comparator
Enrollment 40
Recruitment Details

A total of 71 subjects were screened at 16 centers throughout the United States of America (USA).

First subject enrolled: 20Oct2014. Last subject last visit: 23May2016. Date of early study termination: 21Oct2015

Pre-assignment Details A total of 40 subjects were randomised. Thirty-one subjects were not randomised due to not meeting inclusion/exclusion criteria (20 subjects), withdrawing consent prior to randomisation (2 subjects), and other reasons (9 subjects) including not being able to return for randomisation within 48 hours of the qualifying revascularization.
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description Ticagrelor 90mg twice a day plus aspirin placebo once daily Aspirin 100mg once daily plus ticagrelor placebo twice a day
Period Title: Overall Study
Started 16 24
Sujects Who Received Treatment 16 24
Sujects Who Completed Treatment 10 17
Completed 14 [1] 20 [1]
Not Completed 2 4
Reason Not Completed
No EVR/not PAD/PI decision/RLE bypass             0             4
Lost to Follow-up             1             0
Adverse Event             1             0
[1]
Subjects who discontinued treatment were encouraged to remain in the study.
Arm/Group Title Ticagrelor Aspirin Total
Hide Arm/Group Description Ticagrelor 90mg twice a day plus aspirin placebo once daily Aspirin 100mg once daily plus ticagrelor placebo twice a day Total of all reporting groups
Overall Number of Baseline Participants 16 24 40
Hide Baseline Analysis Population Description
All randomised subjects with the exception of one subject who did not undergo EVR.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 24 participants 40 participants
69.1  (9.15) 67.0  (8.31) 67.9  (8.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 24 participants 40 participants
Female
9
  56.3%
9
  37.5%
18
  45.0%
Male
7
  43.8%
15
  62.5%
22
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 24 participants 40 participants
Hispanic or Latino
3
  18.8%
3
  12.5%
6
  15.0%
Not Hispanic or Latino
13
  81.3%
21
  87.5%
34
  85.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 24 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  25.0%
2
   8.3%
6
  15.0%
White
11
  68.8%
20
  83.3%
31
  77.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   6.3%
2
   8.3%
3
   7.5%
1.Primary Outcome
Title Change From Baseline in Log Transformed Peak Walking Time (PWT) at Week 26 or Early Termination (ET)
Hide Description [Not Specified]
Time Frame 26 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is the analysis population. Six subjects without evaluable baseline were excluded from the analysis.
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:
Ticagrelor 90mg twice a day plus aspirin placebo once daily
Aspirin 100mg once daily plus ticagrelor placebo twice a day
Overall Number of Participants Analyzed 14 20
Mean (95% Confidence Interval)
Unit of Measure: log(Second)
0.0
(-0.2 to 0.2)
0.1
(-0.0 to 0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Aspirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3441
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.1
Estimation Comments Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.
2.Secondary Outcome
Title Change From Baseline in Log Transformed Claudication Onset Time (COT) at Week 26 or Early Termination (ET)
Hide Description [Not Specified]
Time Frame 26 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population is the analysis population. Twelve subjects without evaluable baseline were excluded from the analysis.
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description:
Ticagrelor 90mg twice a day plus aspirin placebo once daily
Aspirin 100mg once daily plus ticagrelor placebo twice a day
Overall Number of Participants Analyzed 12 16
Mean (95% Confidence Interval)
Unit of Measure: log(Second)
0.6
(0.1 to 1.1)
0.5
(0.1 to 0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Aspirin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6186
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.4 to 0.6
Estimation Comments Difference is Ticagrelor - Aspirin. LOCF was used for missing data imputation.
Time Frame 26 weeks treatment period + 30 days followup
Adverse Event Reporting Description Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
 
Arm/Group Title Ticagrelor Aspirin
Hide Arm/Group Description Ticagrelor 90mg twice a day plus aspirin placebo once daily Aspirin 100mg once daily plus ticagrelor placebo twice a day
All-Cause Mortality
Ticagrelor Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   4/16 (25.00%)   2/24 (8.33%) 
Cardiac disorders     
Coronary artery disease  1  1/16 (6.25%)  0/24 (0.00%) 
Infections and infestations     
Cellulitis  1  0/16 (0.00%)  1/24 (4.17%) 
Osteomyelitis  1  0/16 (0.00%)  1/24 (4.17%) 
Nervous system disorders     
Syncope  1  1/16 (6.25%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin ulcer  1  0/16 (0.00%)  1/24 (4.17%) 
Vascular disorders     
Haemorrhage  1  1/16 (6.25%)  0/24 (0.00%) 
Hypotension  1  1/16 (6.25%)  0/24 (0.00%) 
Peripheral artery stenosis  1  0/16 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ticagrelor Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   1/16 (6.25%)   1/24 (4.17%) 
Injury, poisoning and procedural complications     
Procedural haemorrhage  1  1/16 (6.25%)  0/24 (0.00%) 
Vascular disorders     
Arterial occlusive disease  1  0/16 (0.00%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 17.0
This study was terminated early for low enrolment. Less than 25% of anticipated number of subjects were enroled and there was an imbanlance between groups. Therefore, the results should be interpreted with caution.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require Confidential Information to be removed and the sponsor can extend the embargo for an additional 90 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Naeem Khan, MD
Organization: AstraZeneca Pharmaceuticals LP
Phone: +1 302-885-8976
EMail: Naeem.Khan@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02227368     History of Changes
Other Study ID Numbers: D5135L00003
First Submitted: August 19, 2014
First Posted: August 28, 2014
Results First Submitted: May 19, 2017
Results First Posted: June 14, 2017
Last Update Posted: July 19, 2017