The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency

Prince Sultan Cardiac Center, Adult Cardiology Department.

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Aspirin; Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01598337

PSCC002CT

Details and patient eligibility

About

This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.

Full description

Coronary artery bypass graft (CABG) surgery is a commonly used revascularization strategy in patients with severe coronary artery disease. Saphenous vein grafts (SVGs) are the most frequently used conduits for this procedure. Unlike arterial grafts, SVGs are particularly susceptible to occlusive thrombosis during the first post-operative year, which exposes patients to increased risks of death, myocardial infarction, and repeat revascularization.

This study is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG. Patients will undergo planned cardiac Computed tomographic angiography (CTA) predischarge (at 1 week) and CTA/coronary angiography (CAG) at 6 months to 1 year follow-up. CTA at baseline (predischarge) and follow-up CTA/CAG at 6-12 months after CABG will be used to evaluate graft patency.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All comer study where all patients undergoing coronary bypass surgery (CABG) will be randomized to one of the four treatment groups

Exclusion criteria

• Acute myocardial infarction (AMI) or cardiogenic shock
• Aortic dissection
• Mechanical valves.
• Contraindication to antiplatelets or aggrastat.
• Active bleeding or high risk of bleeding.
• History of hemorrhagic stroke any time.
• Recent history of embolic stroke or transient ischemic attack (TIA) less than 3 months.
• Active peptic ulcer disease (PUD).
• Liver derangement.
• Warfarin use.
• Heparin-induced thrombocytopenia (HIT) syndrome.
• Thrombocytopenia (platelet count <100,000/mm3), disorders of platelet function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Aspirin alone

Active Comparator group

Treatment:

Drug: Clopidogrel

Drug: Prasugrel

Drug: Tirofiban

Drug: Aspirin

Tirofoban

Experimental group

Description:

Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding

Treatment:

Drug: Clopidogrel

Drug: Prasugrel

Drug: Tirofiban

Clopidogrel

Experimental group

Description:

Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators

Treatment:

Drug: Clopidogrel

Drug: Prasugrel

Drug: Tirofiban

Prasugrel

Experimental group

Description:

Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators

Treatment:

Drug: Clopidogrel

Drug: Prasugrel

Drug: Tirofiban