Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis

NCT01221402 | Completed Phase 2 DMC

• 2 other identifiers: 10-029R01HL102442
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Aortocoronary Saphenous Vein Bypass Graft Atherosclerosis; Intermediate Saphenous Vein Graft Lesions

Outcome Measures

Primary Outcomes (1)

• change in percent atheroma volume at 12 months intravascular ultrasonography

  12 months

Secondary Outcomes (11)

• change in total and normalized total intermediate SVG lesion atheroma volume

  12 months

• reduction of atheroma volume in the most diseased 10-mm subsegment of the target intermediate lesion

  12 months

• reduction of atheroma volume in the subsegment of the target intermediate lesion with lipid core plaque by near-infrared spectroscopy

  12 months

• lipid core burden index as assessed by near-infrared intracoronary spectroscopy

  12 months

• 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

Study Arms (2)

Extended-release niacin

EXPERIMENTAL

Drug: extended-release niacin (Niaspan)

Placebo

PLACEBO COMPARATOR

Drug: extended-release niacin (Niaspan)

Interventions

extended-release niacin (Niaspan) DRUG

Patients will be randomized in a 1:1 ratio to receive extended-release niacin (1500 - 2000 mg per day) or matching placebo that contains 50 mg of crystalline niacin (enough to cause flushing but has no effect on lipid levels).

Extended-release niacin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

VA North Texas Healthcare System

Dallas, Texas, 75216, United States

Location

Related Publications (2)

• 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 Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial. J Invasive Cardiol. 2015 Oct;27(10):E204-10.

  PMID: 26429851 RESULT

• 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 Hyperemia, and Endothelial Progenitor Cell Mobilization: Insights From the Atherosclerosis Lesion Progression Intervention Using Niacin Extended Release in Saphenous Vein Grafts (ALPINE-SVG) Pilot Trial. J Invasive Cardiol. 2015 Dec;27(12):555-60.

  PMID: 26630643 RESULT

MeSH Terms

Interventions

Niacin

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Emmanouil S Brilakis, MD, PhD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Laboratories

Model Details: Original plan was to enroll 138 subjects, but trial was terminated early and total randomized was 38.

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2015
• Last Updated: August 17, 2017

Record last verified: 2017-08

Locations

US (1)