NCT00624923

Targeting Inflammation Using Salsalate in CardioVascular Disease

Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Joslin Diabetes Center · Academic / Other
• Sex: All
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVE: To determine whether targeting inflammation using salsalate compared with placebo reduces progression of noncalcified coronary artery plaque. DESIGN, SETTING, AND PARTICIPANTS: In the Targeting Inflammation Using Salsalate in Cardiovascular Disease (TINSAL-CVD) trial participants were randomly assigned to 30 months of salsalate or placebo in addition to standard, guideline-based therapies. Randomization was computerized and centrally allocated, with patients, health care professionals, and researchers masked to treatment assignment. Participants were overweight and obese statin-using patients with established, stable coronary heart disease. INTERVENTIONS: Salsalate (3.5 g/d) or placebo orally over 30 months. MAIN OUTCOMES AND MEASURES: The primary outcome was progression of noncalcified coronary artery plaque assessed by multidetector computed tomographic angiography. Secondary outcomes were other measures of safety and efficacy.

Conditions

• Coronary Artery Disease
• Overweight

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-09-01
• Primary completion: 2015-01-01
• Completion: 2016-07-01
• First posted: 2008-02-28
• Last updated: 2019-05-07
• Results posted: 2017-12-12

Locations

5 sites across 1 country: United States