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Trial record 61 of 509 for:    ASPIRIN AND P2

A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS (HouYi)

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: NCT01864005
Recruitment Status : Completed
First Posted : May 29, 2013
Results First Posted : March 2, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-ST or ST Elevation Acute Coronary Syndromes
Interventions Drug: Ticagrelor
Drug: Clopidogrel
Enrollment 60
Recruitment Details First subject enrolled: 15/05/2013, Last subject last visit: 18/03/2014. There were 5 study centers in China, which participated this study.
Pre-assignment Details There was no run-in or any other pre-assignment periods following participant enrollment.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks. Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Period Title: Overall Study
Started 29 31
Completed 26 25
Not Completed 3 6
Reason Not Completed
Protocol Violation             0             1
Withdrawal by Subject             0             1
Incorrect enrolment             1             0
Disease need             1             1
Need GP IIb/IIIa             1             3
Arm/Group Title Ticagrelor Clopidogrel Total
Hide Arm/Group Description Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks. Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks. Total of all reporting groups
Overall Number of Baseline Participants 28 29 57
Hide Baseline Analysis Population Description
Three randomized patients were excluded from the full analysis set (FAS) due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 57 participants
58.75  (10.967) 58.59  (9.789) 58.67  (10.291)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Female
2
   7.1%
8
  27.6%
10
  17.5%
Male
26
  92.9%
21
  72.4%
47
  82.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
28
 100.0%
29
 100.0%
57
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title the Percentage Inhibition of the P2Y12 Receptor
Hide Description Note: the primary endpoint was changed per the statistical analysis plan prior database lock.
Time Frame at 2 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (full analysis set). Three randomized patients were excluded from FAS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: Percentage Inhibition
48.20  (45.410) 9.78  (27.574)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments not adjusted for multiple comparisons. statistical significance level: 0.05
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 38.421
Confidence Interval (2-Sided) 95%
18.559 to 58.283
Estimation Comments [Not Specified]
2.Secondary Outcome
Title the Percentage Inhibition of the P2Y12 Receptor
Hide Description [Not Specified]
Time Frame at 0.5 hour after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: Percentage Inhibition
8.23  (25.810) -3.91  (13.602)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0828
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title the Percentage Inhibition of the P2Y12 Receptor
Hide Description [Not Specified]
Time Frame at 8 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: Percentage Inhibition
67.91  (34.856) 25.38  (32.738)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title the Percentage Inhibition of the P2Y12 Receptor
Hide Description [Not Specified]
Time Frame at 24 hours after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: Percentage Inhibition
79.25  (17.920) 28.76  (26.917)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title the Percentage Inhibition of the P2Y12 Receptor
Hide Description [Not Specified]
Time Frame at 6 weeks after first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
PPS (per-protocol set). Seven randomized patients were excluded from PPS due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, 4) missing blood PRU at 2h after first dose, and 5) use of prohibited medications.
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description:
Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Overall Number of Participants Analyzed 26 27
Mean (Standard Deviation)
Unit of Measure: Percentage Inhibition
83.78  (13.947) 24.22  (33.546)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor, Clopidogrel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 6 weeks for all AEs and another 14 days for SAEs.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor Clopidogrel
Hide Arm/Group Description Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks. Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
All-Cause Mortality
Ticagrelor Clopidogrel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Ticagrelor Clopidogrel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      1/31 (3.23%)    
Gastrointestinal disorders     
Upper gastrointestinal haemorrhage  1/29 (3.45%)  1 0/31 (0.00%)  0
Injury, poisoning and procedural complications     
Drug-induced liver injury  0/29 (0.00%)  0 1/31 (3.23%)  1
1
Term from vocabulary, MedDRA 16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ticagrelor Clopidogrel
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/29 (41.38%)      12/31 (38.71%)    
Blood and lymphatic system disorders     
Anaemia  0/29 (0.00%)  1/31 (3.23%) 
Cardiac disorders     
Hypertensive heart disease  3/29 (10.34%)  2/31 (6.45%) 
Arrhythmia  0/29 (0.00%)  2/31 (6.45%) 
Atrial fibrillation  0/29 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders     
Abdominal discomfort  0/29 (0.00%)  1/31 (3.23%) 
Constipation  0/29 (0.00%)  1/31 (3.23%) 
Diarrhoea  0/29 (0.00%)  1/31 (3.23%) 
Toothache  0/29 (0.00%)  1/31 (3.23%) 
Hepatobiliary disorders     
Hepatic function abnormal  2/29 (6.90%)  3/31 (9.68%) 
Infections and infestations     
Lung infection  1/29 (3.45%)  0/31 (0.00%) 
Orchitis  0/29 (0.00%)  1/31 (3.23%) 
Pharyngitis  1/29 (3.45%)  0/31 (0.00%) 
Postoperative wound infection  0/29 (0.00%)  1/31 (3.23%) 
Puncture site infection  0/29 (0.00%)  1/31 (3.23%) 
Upper respiratory tract infection  1/29 (3.45%)  0/31 (0.00%) 
Investigations     
Blood creatine increased  1/29 (3.45%)  0/31 (0.00%) 
Blood creatinine increased  1/29 (3.45%)  0/31 (0.00%) 
Blood triglycerides increased  1/29 (3.45%)  0/31 (0.00%) 
Metabolism and nutrition disorders     
Hyperuricaemia  3/29 (10.34%)  2/31 (6.45%) 
Hyperlipidaemia  2/29 (6.90%)  1/31 (3.23%) 
Type 2 diabetes mellitus  2/29 (6.90%)  0/31 (0.00%) 
Hypoglycemia  1/29 (3.45%)  0/31 (0.00%) 
Metabolic disorder  0/29 (0.00%)  1/31 (3.23%) 
Musculoskeletal and connective tissue disorders     
Back pain  2/29 (6.90%)  0/31 (0.00%) 
Nervous system disorders     
Headache  1/29 (3.45%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1/29 (3.45%)  0/31 (0.00%) 
Dyspnoea  0/29 (0.00%)  1/31 (3.23%) 
Hypoxia  1/29 (3.45%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders     
Skin haemorrhage  1/29 (3.45%)  0/31 (0.00%) 
Vascular disorders     
Ecchymosis  1/29 (3.45%)  0/31 (0.00%) 
Haematoma  0/29 (0.00%)  1/31 (3.23%) 
Hypertension  1/29 (3.45%)  0/31 (0.00%) 
Hypotension  1/29 (3.45%)  0/31 (0.00%) 
1
Term from vocabulary, MedDRA 16.1
(1) Sample size was relatively small. (2) Study duration with 6 weeks seemed limited. (3) Sampling time-points seemed relatively scarce, such as missing the time point for 1-hour and 4-hour after loading dose.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Judith Hsia
Organization: Astrazeneca
Phone: 1-301-398-0102
EMail: judithhsia@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01864005    
Other Study ID Numbers: D5130L00053
First Submitted: May 24, 2013
First Posted: May 29, 2013
Results First Submitted: February 17, 2015
Results First Posted: March 2, 2015
Last Update Posted: May 15, 2015