Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Targeting Inflammation Using Salsalate in CardioVascular Disease

Lead Sponsor:

Joslin Diabetes Center

Collaborating Sponsors:

Beth Israel Deaconess Medical Center

Tufts Medical Center

Conditions:

Coronary Artery Disease

Overweight

Eligibility:

All Genders

21-75 years

Phase:

PHASE2

PHASE3

Brief 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 atheroscler...

Detailed Description

OBJECTIVE: To determine whether targeting inflammation using salsalate compared with placebo reduces progression of noncalcified coronary artery plaque. DESIGN, SETTING, AND PARTICIPANTS: In the Ta...

Eligibility Criteria

Inclusion

  • 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.
  • 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

  • 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
  • Hemoglobin 2 standard deviations below normal
  • Low platelet count (2 standard deviations below normal)
  • Known bleeding disorder
  • Coumadin (warfarin compounds)
  • History of type 1 diabetes and/or history of ketoacidosis
  • Daily use of NSAIDS (including salsalate) for arthritis
  • History of malignancy, except subjects who have been disease-free for greater than 5 years, or whose only malignancy has been basal or squamous cell skin carcinoma
  • History of drug or alcohol abuse, or current weekly alcohol consumption \>14 units/week (1 unit = 1 beer, 1 glass of wine, 1 mixed cocktail containing 1 ounce of alcohol)
  • Use of probenecid (Benemid, Probalan), sulfinpyrazone (Anturane) or other uricosuric agents
  • Chronic tinnitus.

Key Trial Info

Start Date :

September 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2016

Estimated Enrollment :

340 Patients enrolled

Trial Details

Trial ID

NCT00624923

Start Date

September 1 2008

End Date

July 1 2016

Last Update

May 7 2019

Active Locations (5)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (5 locations)

1

Seacoast Cardiology

York Village, Maine, United States, 03939

2

Joslin Diabetes Center

Boston, Massachusetts, United States, 02215

3

Heart Center of Metrowest

Framingham, Massachusetts, United States, 01702

4

South Shore Internal Medicine

Milton, Massachusetts, United States, 02186