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

NCT ID: NCT01598337

Last Updated: 2012-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aspirin alone

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

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

Tirofiban

Intervention Type DRUG

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

Clopidogrel

Intervention Type DRUG

75 mg orally started 6-8hours before surgery

Prasugrel

Intervention Type DRUG

10 mg daily as per instructions of investigators

Tirofoban

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

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

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

Clopidogrel

Intervention Type DRUG

75 mg orally started 6-8hours before surgery

Prasugrel

Intervention Type DRUG

10 mg daily as per instructions of investigators

Clopidogrel

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

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

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

Clopidogrel

Intervention Type DRUG

75 mg orally started 6-8hours before surgery

Prasugrel

Intervention Type DRUG

10 mg daily as per instructions of investigators

Prasugrel

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

Group Type EXPERIMENTAL

Tirofiban

Intervention Type DRUG

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

Clopidogrel

Intervention Type DRUG

75 mg orally started 6-8hours before surgery

Prasugrel

Intervention Type DRUG

10 mg daily as per instructions of investigators

Interventions

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Aspirin

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

Intervention Type DRUG

Tirofiban

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

Intervention Type DRUG

Clopidogrel

75 mg orally started 6-8hours before surgery

Intervention Type DRUG

Prasugrel

10 mg daily as per instructions of investigators

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince Sultan Cardiac Center, Adult Cardiology Department.

OTHER

Sponsor Role lead

Responsible Party

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Abdulrahman Al-Moghairi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hussein S Al-Amri, MD

Role: STUDY_DIRECTOR

Prince Sultan Cardiac Center (PSCC), Riyadh

Locations

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Prince Sultan Cardiac Center

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Facility Contacts

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Hussein S Alamri, MD

Role: primary

Other Identifiers

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PSCC002CT

Identifier Type: -

Identifier Source: org_study_id

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