Back to resultsA Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS (HouYi)
Primary Purpose
Non-ST or ST Elevation Acute Coronary Syndromes
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Non-ST or ST Elevation Acute Coronary Syndromes focused on measuring Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
Eligibility Criteria
Inclusion Criteria:
- 1. Provision of informed consent prior to any study specific procedures
- 2. Female or male aged at least 18 years
- 3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
- 4. Index event of non-ST or ST segment elevation ACS.
Exclusion Criteria:
- 1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
- 2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
- 3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
- 4. Requires dialysis
- 5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ticagrelor
clopidogrel
Arm Description
Outcomes
Primary Outcome Measures
the Percentage Inhibition of the P2Y12 Receptor
Note: the primary endpoint was changed per the statistical analysis plan prior database lock.
Secondary Outcome Measures
the Percentage Inhibition of the P2Y12 Receptor
the Percentage Inhibition of the P2Y12 Receptor
the Percentage Inhibition of the P2Y12 Receptor
the Percentage Inhibition of the P2Y12 Receptor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01864005
Brief Title
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
Acronym
HouYi
Official Title
A Multicentre, Open-label, Randomized, 6-week, Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel With Aspirin as Background Therapy in Chinese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST or ST Elevation Acute Coronary Syndromes
Keywords
Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Title
clopidogrel
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks.
Primary Outcome Measure Information:
Title
the Percentage Inhibition of the P2Y12 Receptor
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
Secondary Outcome Measure Information:
Title
the Percentage Inhibition of the P2Y12 Receptor
Time Frame
at 0.5 hour after first dose of study drug
Title
the Percentage Inhibition of the P2Y12 Receptor
Time Frame
at 8 hours after first dose of study drug
Title
the Percentage Inhibition of the P2Y12 Receptor
Time Frame
at 24 hours after first dose of study drug
Title
the Percentage Inhibition of the P2Y12 Receptor
Time Frame
at 6 weeks after first dose of study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Provision of informed consent prior to any study specific procedures
2. Female or male aged at least 18 years
3. Females of child-bearing potential must have a negative urine pregnancy test at enrolment and be willing to use reliable contraception
4. Index event of non-ST or ST segment elevation ACS.
Exclusion Criteria:
1.Contraindication or other reason that clopidogrel or ticagrelor should not be administered (eg, hypersensitivity, active bleeding, moderate or severe liver disease, history of previous intracranial bleed, GI bleed within the past 6 months, major surgery within 30 days)
2. Oral anticoagulation therapy or GP IIb/IIIa receptor antagonists therapy within 30 days prior to randomisation or cannot be stopped
3. Ticagrelor or clopidogrel or other P2Y12 inhibitors within 14 days prior to randomisation
4. Requires dialysis
5. Nonselective non-steroidal anti-inflammatory drugs (NSAIDs) and prostacyclins (PGI2) therapy that cannot be stopped
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yundai Chen, Professor
Organizational Affiliation
The General Hospital of People's Liberation Army
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
Country
China
Facility Name
Research Site
City
Shenyang
Country
China
Facility Name
Research Site
City
Tianjin
Country
China
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1828&filename=D5130L00053_CSR_Synopsis.pdf
Description
D5130L00053_CSR_Synopsis
Learn more about this trial
A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS
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