At a glance
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Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)
In Brief
A Phase 3 clinical trial evaluating Salsalate and Placebo for Coronary Artery Disease and Overweight. Completed, enrolled 340 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months