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.

Study Description

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.

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

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 Design

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronary Artery Bypass Surgery

Drug Information available for: Aspirin Prasugrel

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Venous graft patency [ Time Frame: At one year ]
Venous graft patency as assessed by computed tomographic angiography or coronary angiography

Secondary Outcome Measures :

Major cardiac events (MACE) [ Time Frame: At one year ]
Acute myocardial infarction (AMI), Stroke, minor bleeding, death, rate of revascularization

Eligibility Criteria

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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

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

Information from the National Library of Medicine

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

Locations

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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

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

More Information

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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

Additional relevant MeSH terms:

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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

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