Targeting Inflammation Using Salsalate in CardioVascular Disease
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Allison Goldfine Joslin Diabetes Center
Collaborators:
Beth Israel Deaconess Medical Center National Heart, Lung, and Blood Institute (NHLBI) Tufts Medical Center