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

NCT ID: NCT04001894

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-02
• Study Completion Date: 2020-12-09

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.

Conditions

Platelet Reactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ticagrelor

To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease

Group Type: EXPERIMENTAL

Ticagrelor 90mg

Intervention Type: DRUG

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).

Clopidogrel 75mg

Intervention Type: DRUG

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).

Clopidogrel

To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease

Group Type: ACTIVE_COMPARATOR

Ticagrelor 90mg

Intervention Type: DRUG

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).

Clopidogrel 75mg

Intervention Type: DRUG

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).

Interventions

Ticagrelor 90mg

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).

Intervention Type: DRUG

Clopidogrel 75mg

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).

Intervention Type: DRUG

Other Intervention Names

Ticagrelor; Clopidogrel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yue LI

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yue Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Harbin Medical University

Locations

Thrombelastogram

Harbin, Heilongjiang, China

Countries

China

Other Identifiers

20190515

Identifier Type: -

Identifier Source: org_study_id