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

This study is currently recruiting participants.
Verified May 2012 by Prince Sultan Cardiac Center, Adult Cardiology Department.
Sponsor:
Information provided by (Responsible Party):
Abdulrahman Al-Moghairi, Prince Sultan Cardiac Center, Adult Cardiology Department.
ClinicalTrials.gov Identifier:
NCT01598337
First received: May 9, 2012
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: Aspirin
Drug: Tirofiban
Drug: Clopidogrel
Drug: Prasugrel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency

Resource links provided by NLM:


Further study details as provided by Prince Sultan Cardiac Center, Adult Cardiology Department.:

Primary Outcome Measures:
  • Venous graft patency [ Time Frame: At one year ] [ Designated as safety issue: No ]
    Venous graft patency as assessed by computed tomographic angiography or coronary angiography


Secondary Outcome Measures:
  • Major cardiac events (MACE) [ Time Frame: At one year ] [ Designated as safety issue: No ]
    Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization


Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01598337

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

No publications provided

Responsible Party: Abdulrahman Al-Moghairi, Principal Investigator, Prince Sultan Cardiac Center, Adult Cardiology Department.
ClinicalTrials.gov Identifier: NCT01598337     History of Changes
Other Study ID Numbers: PSCC002CT
Study First Received: May 9, 2012
Last Updated: May 14, 2012
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Tirofiban
Clopidogrel
Prasugrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014