Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: North Texas Veterans Healthcare System
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

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