Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis
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|ClinicalTrials.gov Identifier: NCT01560780|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2012
Last Update Posted : April 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass||Drug: Prasugrel Drug: Placebo||Phase 3|
Aortocoronary saphenous vein graft failure is common and is associated with high morbidity and mortality. Thrombus formation plays a critical role in early saphenous vein graft occlusion and may predispose to subsequent atherosclerosis formation. Optical coherence tomography is a novel, high-resolution, intravascular imaging technique that can reliably identify thrombus. Based on the findings of earlier VA Cooperative Studies, aspirin significantly reduces the incidence of early saphenous vein graft failure and is currently used in nearly all patients undergoing coronary bypass graft surgery. Administration of clopidogrel for improving early saphenous vein graft patency has provided conflicting results in small randomized studies. Prasugrel is a novel thienopyridine that provides more rapid, consistent, and intense platelet inhibition than clopidogrel. However, in patients who undergo coronary artery bypass graft surgery, it remains unknown whether prasugrel may decrease thrombus formation in saphenous vein grafts during the first postoperative year, and whether this will result in less saphenous vein graft wall thickening, less lipid deposition in the saphenous vein graft wall and fewer clinical events without increasing the risk for severe bleeding.
Hypothesis: The investigators hypothesize that in patients undergoing clinically-indicated coronary artery bypass graft surgery, administration of prasugrel starting at dismissal from the index coronary bypass graft surgery hospitalization will result in lower prevalence of thrombus formation in a target SVG, as assessed by optical coherence tomography performed 12 months post surgery compared to placebo, with similar incidence of major bleeding.
This is a phase III, single-center, double-blind trial that will randomize 120 patients undergoing clinically-indicated coronary artery bypass graft surgery to prasugrel at a dose of 10 mg daily or matching placebo for 12 months, starting at the time of hospital dismissal from surgery. All patients will receive aspirin. Coronary angiography, optical coherence tomography, intravascular ultrasonography, and near-infrared spectroscopy of one target saphenous vein graft will be performed at 12 months to determine whether compared to placebo, administration of prasugrel will result in:
- Reduction of the prevalence of intragraft thrombus at 12-month follow-up optical coherence tomography imaging (primary efficacy endpoint)
- Similar incidence of severe bleeding using the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) criteria (primary safety endpoint)
- Reduction in the incidence of angiographic SVG failure (defined as 75% SVG diameter stenosis in at least one SVG); reduction in total and normalized total target saphenous vein graft atheroma volume, as assessed by intravascular ultrasonography; and reduction of saphenous vein graft lipid core burden index, as assessed at near-infrared intracoronary spectroscopy at 12-month follow-up cardiac catheterization (secondary endpoints)
- Reduction of major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during follow-up (secondary endpoints)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prasugrel for Prevention of Early Saphenous Vein Graft Thrombosis|
|Actual Study Start Date :||February 1, 2013|
|Estimated Primary Completion Date :||April 30, 2018|
|Estimated Study Completion Date :||May 31, 2018|
Experimental: Arm 1: Prasugrel
prasugrel 10 mg by mouth daily
one 10 mg tablet by mouth daily
Other Name: Effient
Placebo Comparator: Arm 2: Placebo
placebo by mouth once daily
placebo similar in appearance to prasugrel
- prevalence of intragraft thrombus at 12-month follow-up optical coherence tomography imaging [ Time Frame: 12 months ]Optical coherence tomography imaging of thrombus within saphenous vein grafts
- incidence of severe bleeding using the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries (GUSTO) criteria [ Time Frame: 12 months ]Major bleeding defined by the Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries criteria.
- incidence of angiographic saphenous vein graft failure [ Time Frame: 12 months ]angiographic saphenous vein graft failure (defined as =75% SVG diameter stenosis in at least one saphenous vein graft)
- total target saphenous vein graft atheroma volume, as assessed by intravascular ultrasonography [ Time Frame: 12 months ]Intravascular ultrasound imaging of atherosclerosis in saphenous vein grafts.
- saphenous vein graft lipid core burden index, as assessed at near-infrared intracoronary spectroscopy [ Time Frame: 12 months ]Near infrared intracoronary spectroscopy of saphenous vein lipid core burden
- major adverse cardiac events, defined as the composite of death, acute coronary syndrome, or coronary revascularization) during follow-up [ Time Frame: 12 months ]Composite of death, acute coronary syndrome, or coronary revascularization.
- normalized total target saphenous vein graft atheroma volume, as assessed by intravascular ultrasonography [ Time Frame: 12 months ]Intravascular ultrasound assessment of normalized total saphenous vein graft atheroma volume.
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): NCT01560780
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA|
|San Francisco, California, United States, 94121|
|United States, Florida|
|North Florida/South Georgia Veterans Health System, Gainesville, FL|
|Gainesville, Florida, United States, 32608|
|United States, Illinois|
|Jesse Brown VA Medical Center Community-Based Outpatient Clinic Lake Side Divison, Chicago, IL|
|Chicago, Illinois, United States, 60611|
|United States, Texas|
|VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX|
|Dallas, Texas, United States, 75216|
|Principal Investigator:||Shuaib M. Abdullah, MD||VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX|