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

Platelet Reactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001894
• Other study ID #: 20190515
• Status: Completed
• Phase: Phase 4
• Start date: July 2, 2019
• Est. completion date: December 9, 2020

Study information

• Verified date: December 2021
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 9, 2020
• Est. primary completion date: December 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Platelet Reactivity

Intervention

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).
• 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).

Locations

Country	Name	City	State
China	Thrombelastogram	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The platelet inhibition ratio	Thromboelastogram was used to measure platelet inhibition ratio.	up to 3 months
Secondary	The platelet aggregation ratio.	Light transmittance aggregometry method was used to measure platelet aggregation ratio.	up to 3 months