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

Phase 3

• Conditions: Coronary Artery Disease
• Interventions: Drug: Aspirin; Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel

• Registration Number: NCT01598337
• Lead Sponsor: Prince Sultan Cardiac Center, Adult Cardiology Department.

Brief Summary

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

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 Timeline

• Study Start: 2011-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-05-14
• Last Update Submitted: 2012-05-14
• Study First Posted: 2012-05-15
• Last Update Posted: 2012-05-15
• Primary Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin alone	Aspirin	-
Aspirin alone	Clopidogrel	-
Aspirin alone	Prasugrel	-
Clopidogrel	Clopidogrel	Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
Prasugrel	Clopidogrel	Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
Prasugrel	Prasugrel	Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
Aspirin alone	Tirofiban	-
Tirofoban	Tirofiban	Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding
Tirofoban	Clopidogrel	Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding
Tirofoban	Prasugrel	Patient assigned to this arm will receive tirofiban infusion starting approximately six hours post bypass surgery once hemomstasis established and no evidence of bleeding
Clopidogrel	Tirofiban	Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
Clopidogrel	Prasugrel	Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
Prasugrel	Tirofiban	Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators

Primary Outcome Measures

Name	Time	Method
Venous graft patency	At one year	Venous graft patency as assessed by computed tomographic angiography or coronary angiography

Secondary Outcome Measures

Name	Time	Method
Major cardiac events (MACE)	At one year	Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Trial Locations

Locations (1)

Prince Sultan Cardiac Center; 🇸🇦 Riyadh, Saudi Arabia