Status:
COMPLETED
Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis
Lead Sponsor:
North Texas Veterans Healthcare System
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Aortocoronary Saphenous Vein Bypass Graft Atherosclerosis
Intermediate Saphenous Vein Graft Lesions
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Intermediate saphenous vein graft (SVG) lesions are common, have high rates of progression to severe lesions or occlusion, and are associated with high incidence of adverse clinical outcomes. The ALP...
Detailed Description
This is a phase II, single-center, double-blind trial that will randomize 138 prior CABG patients with an intermediate SVG lesion (30%-60% angiographic diameter stenosis) on clinically-indicated coron...
Eligibility Criteria
Inclusion
- Age 18 years or greater
- Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
- Undergoing clinically-indicated coronary and SVG angiography
- Have an intermediate SVG lesion (defined as a lesion 30-60% angiographic diameter stenosis) without previous percutaneous intervention, amenable to examination with IVUS. The lesion should have no thrombus or ulceration and should not be considered responsible for the patient's clinical presentation and referral for graft angiography.
Exclusion
- Known allergy to niacin
- History of statin-induced myopathy
- Positive pregnancy test or breast-feeding
- Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
- Uncontrolled fasting triglyceride levels ( 500 mg/dL)
- Fasting LDL-C \>200 mg/dL
- Fasting HDL-C \>60 mg/dL
- Poorly controlled diabetes (glycosylated hemoglobin levels 10%)
- Current active liver disease or hepatic dysfunction
- AST or ALT \> 2x the upper limit of normal
- Uncontrolled hypothyroidism (Thyroid Stimulating Hormone \>1.5 x upper limit of normal \[ULN\])
- Unexplained creatine kinase elevations (\>3 x ULN)
- Recent history of acute gout
- Serum creatinine \> 2.5 mg/dL
- HIV (due to potential anti-retroviral drug-interactions with niacin)
- Use of high-dose, antioxidant vitamins (vitamins C, E, or beta-carotene) that may interfere with the HDL-raising effect of niacin
- Severe peripheral arterial disease limiting vascular access
- Referral for cardiac catheterization by a physician who is an investigator in the present study.
- Symptoms consistent with moderate or greater severity of congestive heart failure (New York Heart Association - NYHA class III or IV) or whose most recent determination of left ventricular ejection fraction is \<25%
- Uncontrolled hypertension, defined as either a resting diastolic blood pressure of ≥100 mmHg or a resting systolic blood pressure of ≥200 mmHg
- History of allergic reaction to iodine-based contrast agents
- Significant medical or psychological condition that, in the opinion of the investigator, may compromise the patient's safety or successful participation in the study
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01221402
Start Date
October 1 2010
End Date
November 1 2015
Last Update
August 17 2017
Active Locations (1)
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1
VA North Texas Healthcare System
Dallas, Texas, United States, 75216