NCT03381755

Low-dose Ticagrelor in Chinese ACS Patients Undergoing PCI

Comparative Effectiveness and Safety Analysis of Low-dose and Standard-dose Ticagrelor in Chinese Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital of Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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. 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 the effectiveness and safety of low-dose ticagrelor remain yet not very clearly in Chinese patients with acute coronary syndrome undergoing percutaneous coronary intervention.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	half-dose ticagrelor	To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.
DRUG	standard-dose ticagrelor	To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-12-14
• Completion: 2020-12-14
• First posted: 2017-12-22
• Last updated: 2018-09-12

Locations

1 site across 1 country: China