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

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

Detailed Description
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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.

Official Title
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The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Aspirin
* Drug: Tirofiban
* Drug: Clopidogrel
* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin alone<br> | Drug: Aspirin<br>* Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily<br>Drug: Tirofiban<br>* Tirofiban infusion as specified by investigators to start after hemostasis been established<br>Drug: Clopidogrel<br>* 75 mg orally started 6-8hours before surgery<br>Drug: Prasugrel<br>* 10 mg daily as per instructions of investigators<br>|
| Experimental: Tirofoban<br>Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding | Drug: Tirofiban<br>* Tirofiban infusion as specified by investigators to start after hemostasis been established<br>Drug: Clopidogrel<br>* 75 mg orally started 6-8hours before surgery<br>Drug: Prasugrel<br>* 10 mg daily as per instructions of investigators<br>|
| Experimental: Clopidogrel<br>Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators | Drug: Tirofiban<br>* Tirofiban infusion as specified by investigators to start after hemostasis been established<br>Drug: Clopidogrel<br>* 75 mg orally started 6-8hours before surgery<br>Drug: Prasugrel<br>* 10 mg daily as per instructions of investigators<br>|
| Experimental: Prasugrel<br>Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators | Drug: Tirofiban<br>* Tirofiban infusion as specified by investigators to start after hemostasis been established<br>Drug: Clopidogrel<br>* 75 mg orally started 6-8hours before surgery<br>Drug: Prasugrel<br>* 10 mg daily as per instructions of investigators<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Venous graft patency | Venous graft patency as assessed by computed tomographic angiography or coronary angiography | At one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac events (MACE) | Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization | At one year |