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Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis

NCT01221402 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2017-08-17

No results posted yet for this study

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

Interventions

DRUG

extended-release niacin (Niaspan)

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).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • North Texas Veterans Healthcare System

    lead FED

Principal Investigators

  • Emmanouil S Brilakis, MD, PhD · North Texas Veterans Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-10-31
Completion
2015-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01221402 on ClinicalTrials.gov