|Title||Cardiovascular Inflammation Reduction Trial (CIRT)|
|Summary||The purpose of this study is to see if reducing inflammation, by taking a medication, low dose methotrexate (LDM), can lower the risk of having a future heart attack, stroke or dying from heart disease, in people who have already had a heart attack and/or have multi vessel coronary artery disease (more than one coronary artery blocked), and who have diabetes and/or metabolic syndrome. Metabolic syndrome is a combination of findings that includes, elevated triglycerides, low HDL “good cholesterol,” high blood pressure, central (around the waistline ) obesity, and elevated blood sugar.|
CIRT is a randomized trial, which means that participants are put into one of two study groups by a coin-toss type procedure, known as randomization. Half the participants will receive an active study drug, low dose methotrexate (LDM) and half will receive an inactive study drug, known as “placebo.” The study medication, LDM, is a widely used anti-inflammatory treatment for rheumatoid arthritis and it has a well documented safety profile.
Initially, all participants enter a “run-in” phase, when they take the study drug LDM for a period of about six weeks.. During this time patients are watched closely for any problems tolerating LDM. After the run-in period, there is the coin toss, randomization procedure, in which neither the patient nor the research study team knows whether the patient is on LDM or placebo (this is what is meant by double blinded) for the rest of the study period.
Eligible participants are followed up to 5 years. During that period, participants will receive all of their usual medical care. The participants are closely followed by the study team for safety. Initially visits are monthly until six months after randomization when the visits occur every two months.
|Inclusion/Notes||Subjects may be eligible to participate if they have had a heart attack and/or have major blockages in more than one coronary artery, and have been diagnosed with diabetes and/or metabolic syndrome (which is a combination of findings such as high triglycerides, low HDL, “good” cholesterol, high blood pressure, central obesity (around the waistline), and elevated blood sugar.|
|Principal Name||Joshua DeLeon, MD|
|Contact Name||Wendy Drewes, BSN, RN, CCRC (firstname.lastname@example.org)|