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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04001894

Enrollment

Registered

2019-06-28

Start date

2019-07-02

Completion date

2020-12-09

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Reactivity

Keywords

Ticagrelor, Clopidogrel, Coronary artery disease, platelet function tests

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.

Interventions

DRUGTicagrelor 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).

DRUGClopidogrel 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).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The platelet inhibition ratio	up to 3 months	Thromboelastogram was used to measure platelet inhibition ratio.

Secondary

Measure	Time frame	Description
The platelet aggregation ratio.	up to 3 months	Light transmittance aggregometry method was used to measure platelet aggregation ratio.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026