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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01598337
• Other study ID #: PSCC002CT
• Status: Recruiting
• Phase: Phase 3
• First received: May 9, 2012
• Last updated: May 14, 2012
• Start date: April 2011

Study information

• Verified date: May 2012
• Source: Prince Sultan Cardiac Center, Adult Cardiology Department.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin
Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily
• Tirofiban
Tirofiban infusion as specified by investigators to start after hemostasis been established
• Clopidogrel
75 mg orally started 6-8hours before surgery
• Prasugrel
10 mg daily as per instructions of investigators

Locations

Country	Name	City	State
Saudi Arabia	Prince Sultan Cardiac Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Prince Sultan Cardiac Center, Adult Cardiology Department.

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Venous graft patency	Venous graft patency as assessed by computed tomographic angiography or coronary angiography	At one year	No
Secondary	Major cardiac events (MACE)	Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization	At one year	No