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
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Clopidogrel; Ticagrelor; Ticlopidine

Criteria

Inclusion Criteria:

• Female and/or male and ≥ 18 and <80 years of age

• Isolated CABG for the first time

• either on- or off- pump

Exclusion Criteria:

• Combined valvular surgery.

• A second surgery.

• Emergency surgery (a selective operation which change to emergency surgery in some special medical condition).

• Serum creatinine>130μmol/L.

• Oral clopidogrel therapy stops less than 5 days before the surgery.

• Oral anti-coagulation therapy (warfarin) that cannot be withheld.

• History of gastrointestinal or vaginal bleeding, Active pathological bleeding (e.g. active gastroduodenal ulcer or cerebral haemorrhage), history of postoperative gastrointestinal bleeding.

• Uric acid nephropathy, history of postoperative gastrointestinal bleeding.

• History of cerebral haemorrhage.

• Any other condition that may influence platelet count and function.

• Postoperative chest drainage > 200 ml/hr for two hours and more, re-operation for bleeding with persistent cardiac tamponade.

• Treated with IABP or ECMO after operation.

• Any other condition that may put the patient at risk (e.g., recurrent ventricular arrhythmias, peri-operative myocardial infarction, cancer).

• Contraindication to aspirin, clopidogrel and ticagrelor or other reason that study drug should not be administered (e.g., hypersensitivity, moderate or severe liver disease).

• Previous enrollment in other investigational drug or device study within 30 days.

Being or planning to pregnant.