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

Study Overview
=================
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.

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)

Conditions
-----------------
Non-ST or ST Elevation Acute Coronary Syndromes

Intervention / Treatment
-----------------
* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br> | Drug: Ticagrelor<br>* 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.<br>|
| Active Comparator: clopidogrel<br> | Drug: Clopidogrel<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Percentage Inhibition of the P2Y12 Receptor | Note: the primary endpoint was changed per the statistical analysis plan prior database lock. | at 2 hours after first dose of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Percentage Inhibition of the P2Y12 Receptor |  | at 0.5 hour after first dose of study drug | 
| the Percentage Inhibition of the P2Y12 Receptor |  | at 8 hours after first dose of study drug | 
| the Percentage Inhibition of the P2Y12 Receptor |  | at 24 hours after first dose of study drug | 
| the Percentage Inhibition of the P2Y12 Receptor |  | at 6 weeks after first dose of study drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-ST or ST Elevation Acute Coronary Syndromes, Ticagrelor, Clopidogrel, Antiplatelet Effect