Aortocoronary Saphenous Vein Bypass Graft Atherosclerosis Clinical Trial
— ALPINE-SVGOfficial title:
Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis: The Atherosclerosis Lesion Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial
| Verified date | August 2017 |
| Source | North Texas Veterans Healthcare System |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 ALPINE-SVG trial is a randomized-controlled trial of extended-release niacin vs. placebo
in patients with intermediate saphenous vein graft lesions. The main hypothesis of the study
is that compared to placebo, niacin administration will result in reduction in percent
atheroma volume at 12-month follow-up angiography.
| Status | Completed |
| Enrollment | 38 |
| Est. completion date | November 2015 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Age 18 years or greater 2. Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up. 3. Undergoing clinically-indicated coronary and SVG angiography 4. 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 Criteria: 1. Known allergy to niacin 2. History of statin-induced myopathy 3. Positive pregnancy test or breast-feeding 4. Coexisting conditions that limit life expectancy to less than 12 months or that could affect a patient's compliance with the protocol 5. Uncontrolled fasting triglyceride levels ( 500 mg/dL) 6. Fasting LDL-C >200 mg/dL 7. Fasting HDL-C >60 mg/dL 8. Poorly controlled diabetes (glycosylated hemoglobin levels 10%) 9. Current active liver disease or hepatic dysfunction 10. AST or ALT > 2x the upper limit of normal 11. Uncontrolled hypothyroidism (Thyroid Stimulating Hormone >1.5 x upper limit of normal [ULN]) 12. Unexplained creatine kinase elevations (>3 x ULN) 13. Recent history of acute gout 14. Serum creatinine > 2.5 mg/dL 15. HIV (due to potential anti-retroviral drug-interactions with niacin) 16. Use of high-dose, antioxidant vitamins (vitamins C, E, or beta-carotene) that may interfere with the HDL-raising effect of niacin 17. Severe peripheral arterial disease limiting vascular access 18. Referral for cardiac catheterization by a physician who is an investigator in the present study. 19. 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% 20. Uncontrolled hypertension, defined as either a resting diastolic blood pressure of =100 mmHg or a resting systolic blood pressure of =200 mmHg 21. History of allergic reaction to iodine-based contrast agents 22. Significant medical or psychological condition that, in the opinion of the investigator, may compromise the patient's safety or successful participation in the study |
| Country | Name | City | State |
|---|---|---|---|
| United States | VA North Texas Healthcare System | Dallas | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| North Texas Veterans Healthcare System | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States,
Guerra A, Rangan BV, Coleman A, Xu H, Kotsia A, Christopoulos G, Sosa A, Chao H, Han H, Abdurrahim G, Roesle M, de Lemos JA, McGuire DK, Packer M, Banerjee S, Brilakis ES. Effect of Extended-Release Niacin on Carotid Intima Media Thickness, Reactive Hyper — View Citation
Kotsia AP, Rangan BV, Christopoulos G, Coleman A, Roesle M, Cipher D, de Lemos JA, McGuire DK, Packer M, Banerjee S, Brilakis ES. Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis: Insights from the Atherosclerosis Lesion Progressi — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in percent atheroma volume at 12 months intravascular ultrasonography | 12 months | ||
| Secondary | change in total and normalized total intermediate SVG lesion atheroma volume | 12 months | ||
| Secondary | reduction of atheroma volume in the most diseased 10-mm subsegment of the target intermediate lesion | 12 months | ||
| Secondary | reduction of atheroma volume in the subsegment of the target intermediate lesion with lipid core plaque by near-infrared spectroscopy | 12 months | ||
| Secondary | lipid core burden index as assessed by near-infrared intracoronary spectroscopy | 12 months | ||
| Secondary | increase in fibrous cap thickness and reduction in the prevalence and number of microchannels, in the presence and extent of necrotic lipid pool, plaque rupture, calcification, and thrombus, as assessed by optical coherence tomography | 12 months | ||
| Secondary | angiographic intermediate SVG target lesion failure | 12 month | ||
| Secondary | exercise capacity and ischemia, as assessed by exercise stress testing | 12 months | ||
| Secondary | carotid intima-media thickness | 6 and 12 months | ||
| Secondary | reactive hyperemia index | 12 months | ||
| Secondary | EPC-CFU/mL of peripheral blood | 12 months | ||
| Secondary | major adverse cardiac events (defined as the composite of death, acute coronary syndrome, or coronary revascularization) | 12 months |