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Targeting Inflammation Using Salsalate in CardioVascular Disease
NCT00624923 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Salsalate
Study Locations (5)
Massachusetts
- Joslin Diabetes Center — Boston
- Heart Center of Metrowest — Framingham
- South Shore Internal Medicine — Milton
- Newton-Wellesley Cardiology — Newton
Maine
- Seacoast Cardiology — York Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2008-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00624923
The ClinicalTrials.gov registry entry for NCT00624923 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joslin Diabetes Center, which has 87 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00624923 reports 5 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, Maine. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00624923 about?
NCT00624923 is a clinical study titled "Targeting Inflammation Using Salsalate in CardioVascular Disease". 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 salsal...
What is the current status of trial NCT00624923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2008-09. Estimated completion is 2016-07.
What conditions does trial NCT00624923 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Overweight. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00624923?
The interventions under investigation include: Placebo (DRUG), Salsalate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00624923?
This trial is sponsored by Joslin Diabetes Center, which has 87 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00624923 being conducted?
This trial has 5 study locations across Maine, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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