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

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

Tracking Information

• First Submitted Date: May 9, 2012
• First Posted Date: May 15, 2012
• Last Update Posted Date: May 15, 2012
• Study Start Date: April 2011
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Coronary Artery Disease

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 14, 2012): 200
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Saudi Arabia

Administrative Information

• NCT Number: NCT01598337
• Other Study ID Numbers: PSCC002CT
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Abdulrahman Al-Moghairi, Prince Sultan Cardiac Center, Adult Cardiology Department.
• Study Sponsor: Prince Sultan Cardiac Center, Adult Cardiology Department.
• Collaborators: Not Provided

Investigators

• 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