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:
Prince Sultan Cardiac Center, Adult Cardiology Department.
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
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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 May 21, 2013