Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)
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|ClinicalTrials.gov Identifier: NCT00624923|
Recruitment Status : Completed
First Posted : February 28, 2008
Results First Posted : December 12, 2017
Last Update Posted : May 7, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease Overweight||Drug: Salsalate Drug: Placebo||Phase 2 Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)|
|Actual Study Start Date :||September 2008|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||July 2016|
Experimental: 1- Active Pharmacologic
Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
Other Name: Disalcid
Placebo Comparator: 2- Placebo
Placebo matched to Salsalate, seven tablets daily by mouth, divided into two doses, for 30 months
Other Name: Placebo to Salsalate
- Change in Non-calcified Plaque Volume in the Coronary Arteries Assessed by MDCTA From Baseline to 30 Months [ Time Frame: Baseline to 30 months ]
- Change in Cholesterol [ Time Frame: Baseline to 30 mo ]secondary
- Change in Inflammation Marker: CRP [ Time Frame: baseline to 30 mo ]Secondary outcome of change in inflammation marker CRP
- Change in Inflammation in the Liver Associated With Nonalcoholic Steatohepatitis (NASH), ALT [ Time Frame: baseline to 30 mo ]Secondary outcome, change in liver inflammation associated with NASH: ALT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00624923
|United States, Maine|
|York, Maine, United States, 03939|
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Heart Center of Metrowest|
|Framingham, Massachusetts, United States, 01702|
|South Shore Internal Medicine|
|Milton, Massachusetts, United States, 02186|
|Newton, Massachusetts, United States, 02462|
|Study Director:||Francine Welty, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Allison B. Goldfine, MD||Joslin Diabetes Center|
|Principal Investigator:||Ernest Schaefer, MD||Tufts Medical Center|
|Principal Investigator:||Melvin Clouse, MD||Beth Israel Deaconess Medical Center|
|Principal Investigator:||Steven E. Shoelson, MD, PhD||Joslin Diabetes Center|