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
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Condition or disease | Intervention/treatment | Phase |
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Coronary Artery Disease | Drug: Aspirin Drug: Tirofiban Drug: Clopidogrel Drug: Prasugrel | Phase 3 |
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 (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 |

Arm | Intervention/treatment |
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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
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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
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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
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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 |
- Venous graft patency [ Time Frame: At one year ]Venous graft patency as assessed by computed tomographic angiography or coronary angiography
- 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 |
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

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