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

Phase 4

Completed

• Conditions: Platelet Reactivity
• Interventions: Drug: Ticagrelor 90mg; Drug: Clopidogrel 75mg

• Registration Number: NCT04001894
• Lead Sponsor: First Affiliated Hospital of Harbin Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-28
• Study Start: 2019-07-02
• Primary Completion: 2020-12-09
• Study Completion: 2020-12-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ticagrelor	Clopidogrel 75mg	To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease
Clopidogrel	Clopidogrel 75mg	To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
Clopidogrel	Ticagrelor 90mg	To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease
Ticagrelor	Ticagrelor 90mg	To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease

Primary Outcome Measures

Name	Time	Method
The platelet inhibition ratio	up to 3 months	Thromboelastogram was used to measure platelet inhibition ratio.

Secondary Outcome Measures

Name	Time	Method
The platelet aggregation ratio.	up to 3 months	Light transmittance aggregometry method was used to measure platelet aggregation ratio.

Trial Locations

Locations (1)

Thrombelastogram; 🇨🇳 Harbin, Heilongjiang, China