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

NCT ID: NCT02330640

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-10-01

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.

Conditions

Antiplatelet Therapy of Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ticagrelor

90mg Bid for 30days after first dose

Group Type: EXPERIMENTAL

ticagrelor

Intervention Type: DRUG

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.

clopidogrel

75mg Qd for 30days first dose

Group Type: ACTIVE_COMPARATOR

clopidogrel

Intervention Type: DRUG

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.

asprin

100mg Qd all patients will be given asprin 100mg Qd within 24hours after CABG

Group Type: OTHER

asprin

Intervention Type: DRUG

All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhe zheng

Cardiovascular Surgeon Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FuWaiHospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Zzheng

Identifier Type: -

Identifier Source: org_study_id