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

• Sponsor: Prince Sultan Cardiac Center, Adult Cardiology Department. (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01598337
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Aspirin; Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency
• Study Start Date: Apr 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aspirin alone	Drug: Aspirin; Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily; Drug: Tirofiban; Tirofiban infusion as specified by investigators to start after hemostasis been established; Drug: Clopidogrel; 75 mg orally started 6-8hours before surgery; Drug: Prasugrel; 10 mg daily as per instructions of investigators
Experimental: 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	Drug: Tirofiban; Tirofiban infusion as specified by investigators to start after hemostasis been established; Drug: Clopidogrel; 75 mg orally started 6-8hours before surgery; Drug: Prasugrel; 10 mg daily as per instructions of investigators
Experimental: Clopidogrel 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; Tirofiban infusion as specified by investigators to start after hemostasis been established; Drug: Clopidogrel; 75 mg orally started 6-8hours before surgery; Drug: Prasugrel; 10 mg daily as per instructions of investigators
Experimental: Prasugrel Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators	Drug: Tirofiban; Tirofiban infusion as specified by investigators to start after hemostasis been established; Drug: Clopidogrel; 75 mg orally started 6-8hours before surgery; Drug: Prasugrel; 10 mg daily as per instructions of investigators

Outcome Measures

Primary Outcome Measures

1. Venous graft patency [At one year]

   Venous graft patency as assessed by computed tomographic angiography or coronary angiography

Secondary Outcome Measures

1. Major cardiac events (MACE) [At one year]

   Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prince Sultan Cardiac Center	Riyadh		Saudi Arabia

Sponsors and Collaborators

• Prince Sultan Cardiac Center, Adult Cardiology Department.

Investigators

• Study Director: Hussein S Al-Amri, MD, Prince Sultan Cardiac Center (PSCC), Riyadh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abdulrahman Al-Moghairi, Principal Investigator, Prince Sultan Cardiac Center, Adult Cardiology Department.
• ClinicalTrials.gov Identifier: NCT01598337
• Other Study ID Numbers: PSCC002CT
• First Posted: May 15, 2012
• Last Update Posted: May 15, 2012
• Last Verified: May 1, 2012

• Additional relevant MeSH terms: Coronary Artery Disease; Aspirin; Tirofiban; Clopidogrel; Prasugrel Hydrochloride

Study Results

No Results Posted as of May 15, 2012