Targeting Inflammation Using Salsalate in CardioVascular Disease

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Coronary Artery Disease, Overweight

In brief

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.

Key facts

Study ID: NCT00624923
Run by: Joslin Diabetes Center
People needed: 340
Starts: 2008-09-01
Expected to finish: 2016-07-01
Last updated by the study team: 2019-05-07

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Eligibility will be based upon the presence of established coronary artery disease including
previous myocardial infarction (≥6 months ago), or
previous coronary bypass surgery (> 12 months ago), or
stable angina, or
significant non-calcified plaque in at least one coronary artery, or
abnormal exercise tolerance test or
an area of reversible ischemia on nuclear imaging study or pharmacologic stress, with subsequent revascularization, or angioplasty, or
abnormal exercise treadmill stress test with or without nuclear imaging or echocardiography with the following exclusions:
Exclusions based on nuclear imaging:
Transient cavity dilation
More than one vascular territory involved with reversible defect (multiple defects)
Reversible defects involving the anterior wall, septum or apex (LAD territory)
Exclusions based on echocardiography imaging:
More than one vascular territory involved with inducible wall motion abnormalities (multiple defects)
Inducible wall motion abnormalities involving the anterior wall, septum or apex (LAD territory)
Subjects should be at list 6 months after a myocardial infarction and/or revascularization procedure to be eligible.
In addition, subjects must be:
aged 21- 75 years inclusive,
BMI ≥ 27 kg/m2 and ≤ 35 kg/m2 if female and ≤ 40 kg/m2 if male (a BMI ≥24.5 for subjects from Asian origin)
on a stable dose of an HMG CoA reductase inhibitor (statin) for 1 month at screening or unable to tolerate a statin,
have normal renal function, (note estimated creatinine clearance calculated using Cockcroft-Gault (CG) equation ≥60 at screening [eCrCLCG (ml/min) = [(140 - age) x weight (kg)]/[SCr(mg/dl) x 72] x [0.85 if female],
have liver function (ALT, AST) < 3 times upper limits of normal),
normal thyroid function (on stable dose replacement therapy is acceptable),
if women are of child bearing potential they must have a pregnancy test prior to the CT angio and use contraception for the remainder of the study
patients with T2D must have a fasting glucose of ≤ 200 mg/dl at screening and cannot be treated with thiazolidinedione class agents or insulin or Extendin-4 (Byetta) therapy.

You may not qualify if…

Unstable angina (increase in frequency or severity of anginal episodes or development of chest pain at rest)
significant obstructive disease (≥ 70%) in left main coronary artery, ostial LAD or three-vessel disease by MDCTA
Significant heart failure (NYHA class III and IV)
Current atrial fibrillation or Wolf-Parkinson-White (WPW) syndrome
Allergy to beta-blocker in subjects with resting heart rate > 65 bpm
Systolic blood pressure > 160 mm Hg
Diastolic BP > 100 mm Hg
Persons with allergies to contrast material
History of asthma if unable to tolerate beta blocker
Allergy to iodinated contrast material or shellfish
Allergy to nitroglycerin
BMI > 35 kg/m2 if female and > 40 kg/m2 if male
Body weight > 350 lbs
Use of drugs for weight loss [e.g. Xenical (orlistat), Meridia (sibutramine), Acutrim (phenylpropanolamine) or similar over-the counter medications] within three months of screening
Surgery within 30 days of screening
History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV)
Poor mental function or history of dementia/ Alzheimer's Disease or on medications used for treatment of dementia [e.g. Tacrine (Cognex), Rivastigmine (Exelon), Galantamine (Razadyne, Reminyl), Donepezil (Aricept), Memantine (Namenda)] or any other reason to expect patient difficulty in complying with the requirements of the study
Medicine for erectile dysfunction within 72 hours prior to MDCTA
History of significant chronic rheumatologic or other chronic inflammatory disease (including foot ulcers)
Prior hemorrhagic stroke
persons with known aspirin allergy
Use of continuous oral corticosteroid treatment (more than 2 weeks), or patients requiring corticosteroids within 3 months
Anti-diabetic medication including thiazolidinedione (pioglitazone or rosiglitazone), or insulin or Extendin-4 (Byetta)
History of peptic ulcer or gastritis within 5 years
Positive stool guaiac

Where it is running

Seacoast Cardiology — York Village, Maine, United States
Joslin Diabetes Center — Boston, Massachusetts, United States
Heart Center of Metrowest — Framingham, Massachusetts, United States
South Shore Internal Medicine — Milton, Massachusetts, United States
Newton-Wellesley Cardiology — Newton, Massachusetts, United States

Full record on ClinicalTrials.gov

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