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

This protocol is designed to evaluate the effect of antiplatelets (Tirafiban and Prasugrel) on the incidence of early and intermediate graft patency after CABG.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin; Drug: Tirofiban; Drug: Clopidogrel; Drug: Prasugrel

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • Recruiting
    • Prince Sultan Cardiac Center
    • Contact: Hussein S Alamri, MD; Email: amriheart@hotmail.com
    • Principal Investigator: Antonio Calafiore
    • Principal Investigator: Hussein S Alamri, MD
    • Principal Investigator: Abdulrahman M almoghairi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous graft patency	Venous graft patency as assessed by computed tomographic angiography or coronary angiography	At one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major cardiac events (MACE)	Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization	At one year

Collaborators and Investigators

• Sponsor: Prince Sultan Cardiac Center, Adult Cardiology Department.
• Investigators: Study Director: Hussein S Al-Amri, MD, Prince Sultan Cardiac Center (PSCC), Riyadh

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (Estimate): May 15, 2012

Study Record Updates

• Last Update Posted (Estimate): May 15, 2012
• Last Update Submitted That Met QC Criteria: May 14, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel; Tirofiban; Prasugrel Hydrochloride
• Other Study ID Numbers: PSCC002CT