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

Prince Sultan Cardiac Center, Adult Cardiology Department.200 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Coronary Artery Disease

Interventions

AspirinDRUG

Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily

TirofibanDRUG

Tirofiban infusion as specified by investigators to start after hemostasis been established

ClopidogrelDRUG

75 mg orally started 6-8hours before surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Prince Sultan Cardiac Center

Riyadh, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

Venous graft patency

Venous graft patency as assessed by computed tomographic angiography or coronary angiography

Time frame: At one year

Secondary Outcomes

Major cardiac events (MACE)

Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Time frame: At one year

Data from ClinicalTrials.gov

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