Antiplatelet Effects of Low-dose Ticagrelor and Standard-dose Clopidogrel in Chinese ACS Patients
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|ClinicalTrials.gov Identifier: NCT03381742|
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Drug: Ticagrelor Drug: ticagrelor Drug: clopidogrel||Phase 2 Phase 3|
Dual Antiplatelet Therapy (DAPT) with aspirin and P2Y12 receptor inhibitor remains a cornerstone in the secondary prevention of coronary artery disease (CAD). Clopidogrel is one of the most commonly used antithrombotic agent that inhibits the platelet P2Y(12) adenosine diphosphate (ADP) receptor.
Ticagrelor is an oral, reversibly-binding, direct-acting P2Y12 receptor antagonist used clinically for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS). Guideline recommendations on the use of dual antiplatelet therapy have been formulated that ticagrelor 90 mg twice daily plus aspirin in preference to clopidogrel 75mg daily plus aspirin for ACS patients. Recent study found that ticagrelor 90mg twice a day orally could significantly reduce the occurrence of clopidogrel resistance and adverse cardiovascular events. The previous studies have reported that half-dose ticagrelor had the similar inhibitory effect on platelet aggregation as the standard-dose ticagrelor, which was significantly stronger than that in the clopidogrel group. One-quarter standard-dose ticagrelor provided greater degree of platelet inhibition than standard dose clopidogrel in Chinese patients with stable CAD. But large-scale clinical trials are still needed to confirm the effects of low-dose ticagrelor on platelet function in Chinese patients with coronary heart disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||"Real-World" Comparison of the Antiplatelet Effects of Low-dose Ticagrelor and Standard-dose Clopidogrel in Chinese ACS Patients|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||December 13, 2019|
|Estimated Study Completion Date :||February 13, 2020|
Experimental: ticagrelor 45mg bidpo.
To observe ticagrelor 45mg bidpo. on platelet aggregation in patients with acute coronary syndrome.
half-dose ticagrelor treatment (90 mg loading dose, then 45 mg twice daily)for 5 days.
Experimental: ticagrelor 90mg qdpo.
To observe ticagrelor 90mg qdpo. on platelet aggregation in patients with acute coronary syndrome.
half-dose ticagrelor treatment (90 mg loading dose, then 90 mg once daily) for 5 days.
Active Comparator: ticagrelor 90mg bidpo.
To observe standard-dose ticagrelor on platelet aggregation in patients with acute coronary syndrome.
standard-dose ticagrelor treatment (180 mg loading dose, then 90 mg twice daily) for 5 days.
Active Comparator: clopidogrel 75mg qdpo.
To observe standard-dose clopidogrel on platelet aggregation in patients with acute coronary syndrome.
standard-dose clopidogrel treatment (300 mg loading dose, then 75 mg once daily) for 5 days.
- The platelet aggregation rate [ Time Frame: up to 5 days ]thromboela-stogram
- Side effects including bleeding,dyspnea and arrhythmia [ Time Frame: up to 5 days ]
- Adverse events including myocardial infarction, death, stroke, re-hospitalization for cardiovascular diseases and ischemia events [ Time Frame: up to 5 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381742
|Contact: Meijiao He, MMfirstname.lastname@example.org|
|Beijing, China, 100001|
|Contact: Liu Yang 86-010-801231171|
|Principal Investigator:||Yue Li, MD||Cardiovascular Department, the First Affiliated Hospital of Harbin Medical University|