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

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ClinicalTrials.gov Identifier: NCT01598337
Recruitment Status : Unknown
Verified May 2012 by Abdulrahman Al-Moghairi, Prince Sultan Cardiac Center, Adult Cardiology Department..
Recruitment status was:  Recruiting
First Posted : May 15, 2012
Last Update Posted : May 15, 2012
Sponsor:
Information provided by (Responsible Party):
Abdulrahman Al-Moghairi, Prince Sultan Cardiac Center, Adult Cardiology Department.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2011
Estimated Primary Completion Date : December 2013

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Venous graft patency [ Time Frame: At one year ]
    Venous graft patency as assessed by computed tomographic angiography or coronary angiography


Secondary Outcome Measures :
  1. Major cardiac events (MACE) [ Time Frame: At one year ]
    Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598337


Locations
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Saudi Arabia
Prince Sultan Cardiac Center Recruiting
Riyadh, Saudi Arabia
Contact: Hussein S Alamri, MD       amriheart@hotmail.com   
Principal Investigator: Antonio Calafiore         
Principal Investigator: Hussein S Alamri, MD         
Principal Investigator: Abdulrahman M almoghairi, MD         
Sponsors and Collaborators
Prince Sultan Cardiac Center, Adult Cardiology Department.
Investigators
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Study Director: Hussein S Al-Amri, MD Prince Sultan Cardiac Center (PSCC), Riyadh
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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    Key Record Dates
Last Update Posted: May 15, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Tirofiban
Clopidogrel
Prasugrel Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists