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Targeting Inflammation Using Salsalate in CardioVascular Disease

NCT00624923 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2019-05-07

Study results available
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Summary

The hypothesis is that western lifestyle, with sedentary behaviors and caloric excess promote a chronic, subacute inflammatory state that participates in the development and progression of atherosclerosis. We will evaluate the effects of targeting inflammation using the anti-inflammatory drug salsalate, compared to placebo, on coronary artery plaque volume assessed by multi-detector computed tomographic angiography (MDCTA). The TINSAL-CVD study is a randomized, double-masked, placebo-controlled, 2 arm, clinical trial.

The purpose of the study is to compare the effect of salsalate or placebo on sub-acute inflammation and coronary plaque, in people with cardiovascular disease. Participants are randomized to active intervention (salsalate) or placebo interventions for a period of 30 months. The primary endpoint is change in plaque volume in the coronary arteries assessed by MDCTA from baseline to 30 months.

Conditions

Interventions

DRUG

Salsalate

Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months

DRUG

Placebo

Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months

Sponsors & Collaborators

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Tufts Medical Center

    collaborator OTHER

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

    collaborator NIH

  • Joslin Diabetes Center

    lead OTHER

Principal Investigators

  • Francine Welty, MD · Beth Israel Deaconess Medical Center

  • Allison B. Goldfine, MD · Joslin Diabetes Center

  • Ernest Schaefer, MD · Tufts Medical Center

  • Melvin Clouse, MD · Beth Israel Deaconess Medical Center

  • Steven E. Shoelson, MD, PhD · Joslin Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-01-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00624923 on ClinicalTrials.gov