Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antiplatelet Therapy of Coronary Artery Bypass
Keywords: CABG
antiplatelet therapy
ticagrelor
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center prospective randomized controlled study
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: IPA at 2hours
timeFrame: 2 hours after the first dose of study drug
Secondary outcomes:
measure: the inhibition of platelet function (IPA%) measured by LTA at 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
timeFrame: 0h, 8h, 24h, 3day, and 30day after the first dose of study drug
measure: the platelet reactivity index at 0h, 2h, 8h, 24h，3day, and 30days
timeFrame: 0h, 2h, 8h, 24h，3day, and 30day after the first dose of study drug
Other outcomes:
measure: The Number of Bleeding events according to BARC definition.
timeFrame: 30 days after the operation
measure: The number of MACE events including all-cause mortality， myocardial infarction, urgent re-operation for heart, cerebral infarction, cerebral hemorrhage.
timeFrame: 30 days after the operation
Locations:
city: Beijing
country: China
facility: FuWaiHospital
state: Beijing
Study officials:
References: