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

Sponsor

First Affiliated Hospital of Harbin Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04001894

Collaborator

(none)

Enrollment

Location

Arms

17.3

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Reactivity	Drug: Ticagrelor 90mg Drug: Clopidogrel 75mg	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 2, 2019

Actual Primary Completion Date :

Dec 9, 2020

Actual Study Completion Date :

Dec 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor To observe the safety and efficacy of standard-dose ticagrelor in Chinese patients with Stable Coronary Artery Disease	Drug: 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). Other Names: Ticagrelor 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). Other Names: Clopidogrel
Active Comparator: Clopidogrel To observe the safety and efficacy of standard-dose clopidogrel in Chinese patients with Stable Coronary Artery Disease	Drug: 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). Other Names: Ticagrelor 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). Other Names: Clopidogrel

Arm

Intervention/Treatment

Experimental: Ticagrelor

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

Drug: 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).

Other Names:

Ticagrelor

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).

Other Names:

Clopidogrel

Active Comparator: Clopidogrel

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

Drug: 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).

Other Names:

Ticagrelor

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).

Other Names:

Clopidogrel

Outcome Measures

Primary Outcome Measures

The platelet inhibition ratio [up to 3 months]
Thromboelastogram was used to measure platelet inhibition ratio.

Secondary Outcome Measures

The platelet aggregation ratio. [up to 3 months]
Light transmittance aggregometry method was used to measure platelet aggregation ratio.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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