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| Sponsor: | Joslin Diabetes Center |
|---|---|
| Collaborators: |
Beth Israel Deaconess Medical Center Tufts Medical Center |
| Information provided by: | Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT00624923 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease Overweight |
Drug: Salsalate Drug: Placebo |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD) |
| Estimated Enrollment: | 278 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1- Active Pharmacologic
Salsalate
|
Drug: Salsalate
Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
Other Name: Disalcid
|
|
Placebo Comparator: 2
Placebo
|
Drug: Salsalate
Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months
Other Name: Disalcid
Drug: Placebo
Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
|
Eligibility| Ages Eligible for Study: | 21 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Eligibility will be based upon the presence of established coronary artery disease including
Exclusions based on nuclear imaging:
Exclusions based on echocardiography imaging:
Subjects should be at list 6 months after a myocardial infarction and/or revascularization procedure to be eligible.
In addition, subjects must be:
Subjects must be willing to have at least three visits at the Beth Israel-Deaconess Medical Center/Joslin Diabetes Center with a baseline and a 30-month follow-up series of imaging studies including CT angiography of the coronary arteries and imaging of the aorta, abdominal adiposity and liver, and interim visit at 1 year.
Exclusion Criteria:
Contacts and Locations| Contact: Allison B. Goldfine, MD | 617-309-2643 | allison.goldfine@joslin.harvard.edu |
| United States, Maine | |
| Seacoast Cardiology | Recruiting |
| York, Maine, United States | |
| Contact: Benjamin Lowenstein, MD 603-363-6136 benlowe@maine.rr.com | |
| Principal Investigator: Benjamin Lowenstein, MD | |
| United States, Massachusetts | |
| The Medical Group | Withdrawn |
| Beverly, Massachusetts, United States, 01915 | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Francine Welty, MD 617-632-7659 fwelty@bidmc.harvard.edu | |
| Principal Investigator: Francine Welty, MD | |
| Joslin Diabetes Center | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Allison B. Goldfine, MD 617-309-2643 allison.goldfine@joslin.harvard.edu | |
| Contact: Iris Marquis, NP 617-309-4736 iris.marquis@joslin.harvard.edu | |
| Principal Investigator: Allison B. Goldfine, MD | |
| Cardiovascular Research Associates | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Ernst Schaefer, MD 781-258-1454 ernest.schaefer@tufts.edu | |
| Contact: Michael Dansinger, MD 617-556-3100 mdansinger@tuftsmedicalcenter.org | |
| Sub-Investigator: Ernest Schaefer, MD | |
| Principal Investigator: Michael Dansinger, MD | |
| Heart Center of Metrowest | Recruiting |
| Framingham, Massachusetts, United States, 01702 | |
| Contact: Jan Johnson 508-875-4811 | |
| Principal Investigator: Harvey Goldfine, MD | |
| South Shore Internal Medicine | Recruiting |
| Milton, Massachusetts, United States | |
| Contact: Jon Cronin 617-698-8855 Jon_Cronin@miltonhospital.org | |
| Principal Investigator: Jon Cronin, MD | |
| Newton-Wellesley Cardiology | Recruiting |
| Newton, Massachusetts, United States | |
| Contact: Guilia Sheftel, MD 617-527-1335 gsheftel@partners.org | |
| Contact: Joel Rubenstein, MD 617 527-1335 jjrubenstein@partners.org | |
| Principal Investigator: Joel Rubenstein, MD | |
| Sub-Investigator: Guilia Sheftel, MD | |
| 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 |
More Information
| Responsible Party: | Allison B. Goldfine, MD, Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT00624923 History of Changes |
| Other Study ID Numbers: | CHS 06-13, NHLBI: P50 HL083813;, CCI: 2006-P-00175, CHS: 06-13 |
| Study First Received: | February 19, 2008 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Coronary Artery Disease Inflammation Overweight Metabolic Syndrome Salsalate |
|
Cardiovascular Diseases Coronary Artery Disease Myocardial Ischemia Coronary Disease Inflammation Overweight Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes Body Weight Signs and Symptoms Sodium Salicylate Salicylsalicylic acid |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |