Clinical trial NCT04001894: Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease
Official title: Ticagrelor and Clopidogrel on Platelet Effects in Chinese Patients With Stable Coronary Artery Disease: a Randomized, Single-blind, Crossover Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Platelet Reactivity
Keywords: Ticagrelor
Clopidogrel
Coronary artery disease
platelet function tests
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The platelet inhibition ratio
timeFrame: up to 3 months
Secondary outcomes:
measure: The platelet aggregation ratio.
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: Thrombelastogram
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Yue Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: