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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.

Tracking Information
First Submitted Date  ICMJE May 9, 2012
First Posted Date  ICMJE May 15, 2012
Last Update Posted Date May 15, 2012
Study Start Date  ICMJE April 2011
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
Venous graft patency [ Time Frame: At one year ]
Venous graft patency as assessed by computed tomographic angiography or coronary angiography
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
Major cardiac events (MACE) [ Time Frame: At one year ]
Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency
Official Title  ICMJE The Effect Of Antiplatelets Therapy, Tirafiban, Prasugrel, And Aspirin On Saphenous Vein Coronary Artery Bypass Graft Patency
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Aspirin alone
    Interventions:
    • Drug: Aspirin
    • Drug: Tirofiban
    • Drug: Clopidogrel
    • Drug: Prasugrel
  • 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
    Interventions:
    • Drug: Tirofiban
    • Drug: Clopidogrel
    • Drug: Prasugrel
  • 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
    Interventions:
    • Drug: Tirofiban
    • Drug: Clopidogrel
    • Drug: Prasugrel
  • Experimental: Prasugrel
    Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
    Interventions:
    • Drug: Tirofiban
    • Drug: Clopidogrel
    • Drug: Prasugrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 14, 2012)
200
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01598337
Other Study ID Numbers  ICMJE PSCC002CT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abdulrahman Al-Moghairi, Prince Sultan Cardiac Center, Adult Cardiology Department.
Study Sponsor  ICMJE Prince Sultan Cardiac Center, Adult Cardiology Department.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hussein S Al-Amri, MD Prince Sultan Cardiac Center (PSCC), Riyadh
PRS Account Prince Sultan Cardiac Center, Adult Cardiology Department.
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP