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

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01598337
Enrollment
200
Registered
2012-05-15
Start date
2011-04-30
Completion date
Unknown
Last updated
2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DRUGAspirin

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

DRUGTirofiban

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

DRUGClopidogrel

75 mg orally started 6-8hours before surgery

DRUGPrasugrel

10 mg daily as per instructions of investigators

Sponsors

Prince Sultan Cardiac Center, Adult Cardiology Department.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Venous graft patencyAt one yearVenous graft patency as assessed by computed tomographic angiography or coronary angiography

Secondary

MeasureTime frameDescription
Major cardiac events (MACE)At one yearAcute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026