Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease

Study Overview
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Brief Summary
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Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. Increased evidence showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. Therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in Chinese patients with stable CAD.

Detailed Description
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Ticagrelor is a novel, direct-acting, reversibly binding P2Y12 receptor antagonist. When related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. Current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in CAD patients. However, increasing evidence showed ticagrelor increased the risk of bleeding. Recent studies showed that P2Y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with DAPT. So the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in Chinese patients with stable CAD.

Official Title
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Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study

Conditions
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Platelet Reactivity

Intervention / Treatment
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* Drug: Ticagrelor 90mg
* Drug: Clopidogrel 75mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:• Aged ≥18 years Subjects had documented with stable CAD Women were required to be postmenopausal or surgically sterile Patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization Patients were required to discontinue aspirin at least 14 days before randomization. Exclusion Criteria: Acute coronary syndrome Planned use of glycoprotein IIb/IIIa receptor inhibitors, adenosine diphosphate (ADP) receptor antagonists other than the study medication, or anticoagulant therapy during the study period Platelet count <10×10^4/μL Hstory of bleeding tendency Diagnosed as respiratory or circulatory instability Allergy to ticagrelor or clopidogrel

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br>To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease | Drug: Ticagrelor 90mg<br>* Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).<br>* Other names: Ticagrelor;Drug: Clopidogrel 75mg<br>* Clopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily).<br>* Other names: Clopidogrel;|
| Active Comparator: Clopidogrel<br>To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease | Drug: Ticagrelor 90mg<br>* Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).<br>* Other names: Ticagrelor;Drug: Clopidogrel 75mg<br>* Clopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily).<br>* Other names: Clopidogrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The platelet inhibition ratio | Thromboelastogram was used to measure platelet inhibition ratio. | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The platelet aggregation ratio. | Light transmittance aggregometry method was used to measure platelet aggregation ratio. | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Clopidogrel, Coronary artery disease, platelet function tests