The Effect Of Antiplatelets Therapy On Saphenous Vein Coronary Artery Bypass Graft Patency
NCT ID: NCT01598337
Last Updated: 2012-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2011-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aspirin alone
Aspirin
Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily
Tirofiban
Tirofiban infusion as specified by investigators to start after hemostasis been established
Clopidogrel
75 mg orally started 6-8hours before surgery
Prasugrel
10 mg daily as per instructions of investigators
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
Tirofiban
Tirofiban infusion as specified by investigators to start after hemostasis been established
Clopidogrel
75 mg orally started 6-8hours before surgery
Prasugrel
10 mg daily as per instructions of investigators
Clopidogrel
Patients receive oral clopidogrel 75 mg 6-8 hours before coronary bypass surgery and continue daily mentenance dose as per instruction by investigators
Tirofiban
Tirofiban infusion as specified by investigators to start after hemostasis been established
Clopidogrel
75 mg orally started 6-8hours before surgery
Prasugrel
10 mg daily as per instructions of investigators
Prasugrel
Patients started on prasugrel 6 hours post surgery 10 mg then continue on daily 10mg as per instruction by investigators
Tirofiban
Tirofiban infusion as specified by investigators to start after hemostasis been established
Clopidogrel
75 mg orally started 6-8hours before surgery
Prasugrel
10 mg daily as per instructions of investigators
Interventions
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Aspirin
Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily
Tirofiban
Tirofiban infusion as specified by investigators to start after hemostasis been established
Clopidogrel
75 mg orally started 6-8hours before surgery
Prasugrel
10 mg daily as per instructions of investigators
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Prince Sultan Cardiac Center, Adult Cardiology Department.
OTHER
Responsible Party
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Abdulrahman Al-Moghairi
Principal Investigator
Principal Investigators
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Hussein S Al-Amri, MD
Role: STUDY_DIRECTOR
Prince Sultan Cardiac Center (PSCC), Riyadh
Locations
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Prince Sultan Cardiac Center
Riyadh, , Saudi Arabia
Countries
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Facility Contacts
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Other Identifiers
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PSCC002CT
Identifier Type: -
Identifier Source: org_study_id
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