Coronary Artery Disease Clinical Trial
Official title:
Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)
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.
OBJECTIVE:
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.
INTERVENTIONS:
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
| Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
| Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
| Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
| Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
| Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
| Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
| Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
| Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
| Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
| Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
| Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
| Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
| Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
| Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
| Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
| Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
| Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |