NCT02330640

A Single-center, Prospective,Randomized Study of Antiplatelet Effects of Ticagrelor Versus Clopidogrel in Patients With Dual Anti-platelet Therapy After Coronary Artery Bypass Grafting

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to demonstrate that the onset of the antiplatelet effect of 90mg bid dose ticagrelor is more rapid and greater than 75 mg qd dose clopidogrel in patients undergoing CABG surgery.

Detailed description

Patients undergoing coronary artery surgery routinely receive aspirin therapy, as a standard treatment for preserving bypass graft patency. Although the dual antiplatelet therapy post CABG has not been recommended by guideline, present studies indicated the patients could benefit from the dual anti-platelet therapy. Using clopidogrel+aspirin could significantly reduce the early saphenous vein graft occlusion. . Many surgeons empirically prescribe dual anti-platelet therapy in spite of the indeterminacy of the clinical effects. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD. ticagrelor is a novel, reversibly binding, oral, direct-acting P2Y12-receptor antagonist. The ONSET/OFFSET Study also shows that ticagrelor achieved much rapid and greater platelet inhibition than high-loading-dose clopidogrel in patients with stable CAD.

Conditions

• Antiplatelet Therapy of Coronary Artery Bypass

Interventions

Type	Name	Description
DRUG	ticagrelor	After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.
DRUG	clopidogrel	After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.
DRUG	asprin	All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2015-01-05
• Last updated: 2017-05-09

Locations

1 site across 1 country: China