Cardiovascular Inflammation Reduction Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Cardiovascular Disease

In brief

The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).

Key facts

Study ID: NCT01594333
Run by: Brigham and Women's Hospital
People needed: 4786
Starts: 2013-04-01
Expected to finish: 2019-10-30
Last updated by the study team: 2020-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years at screening
Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography.
To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.
To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.
History of type 2 diabetes or metabolic syndrome at time of study enrollment
Willingness to participate as evidenced by signing the study informed consent

You may not qualify if…

Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years;
Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul
Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN);
Creatinine clearance < 40 ml/min as estimated with the Cockcroft-Gault equation;
History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed.
Men who plan to father children during the study period or who are unwilling to use effective forms of contraception.
Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible;
Current indication for methotrexate therapy;
Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions.
Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol.
New York Heart Association Class IV congestive heart failure.

Where it is running

Appalachian Research Associates — Fort Payne, Alabama, United States
Avant Research Associates, LLC — Guntersville, Alabama, United States
Saadat Ansari MD LLC — Huntsville, Alabama, United States
University of South Alabama: Division of Clinical Research — Mobile, Alabama, United States
Heart Vascular of Northern Arizona — Cottonwood, Arizona, United States
CardioVascular Associates of Mesa — Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research — Phoenix, Arizona, United States
Scottsdale Medical Imaging — Scottsdale, Arizona, United States
The Heart Clinic — Scottsdale, Arizona, United States
Pima Heart — Tucson, Arizona, United States
Southern Arizona VA Health Care System — Tucson, Arizona, United States
Arkansas Cardiology — Little Rock, Arkansas, United States
Arkansas Heart Hospital — Little Rock, Arkansas, United States
Oracle Clinical Research, Inc. — Anaheim, California, United States
Medical Group of Culver City — Culver City, California, United States
Touro University California- Solano County Affiliated Clinics — Fairfield, California, United States
University Of California San Francisco — Fresno, California, United States
VACCHCS — Fresno, California, United States
UCSD Sulpizio Cardiovascular Center — La Jolla, California, United States
University Of California San Diego — La Jolla, California, United States
Desert Medical Care & Wellness — La Quinta, California, United States
Kumar Medical Corporation — Lancaster, California, United States
Loma Linda University Health — Loma Linda, California, United States
VA Loma Linda Healthcare System — Loma Linda, California, United States
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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