NCT01221402|CompletedPhase 2DMC
Effect of Extended-Release Niacin on Saphenous Vein Graft Atherosclerosis
ALPINE-SVG
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Sponsor study identifier
Secondary identifiers
NIH
interventional
38
1 country
1
Study Start
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
November 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2010
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2010
Actual (reported)October 15, 2010
Actual (reported)October 2014
Actual (reported)November 2015
Actual (reported)change in percent atheroma volume at 12 months intravascular ultrasonography
12 months
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
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).
VA North Texas Healthcare System
Dallas, Texas, 75216, United States
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.
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.
Emmanouil S Brilakis, MD, PhD
North Texas Veterans Healthcare System
38 participants (actual enrollment reported by the registry).
First Submitted
October 14, 2010
First Posted
October 15, 2010
Study Start
Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis
Contact the study team to confirm eligibility.
October 2010
This date has not been verified as actual or estimated.
Primary Completion
October 2014
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
August 17, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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