Cardiovascular Inflammation Reduction Trial (CIRT): A randomized double-blind placebo controlled event-driven trial of weekly low-dose methotrexate (LDM) in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with type 2 diabetes or metabolic syndrome
Brief Description Of Study
This is an event-driven, multi-center, randomized, double-blind, placebo-controlled trial to determine whether methotrexate reduces heart attacks, strokes, or death in people who have already had at least one heart attack and have type 2 diabetes or metabolic syndrome. Metabolic syndrome is defined as a combination of problems including a large waistline, high triglyceride level, low HDL level, high blood pressure, and high fasting blood sugar. The combination of problems tends to occur together and raise your risk of heart disease and diabetes. Methotrexate is a drug commonly used to reduce inflammation (pain and swelling) in the joints of people with rheumatoid arthritis. It has been noticed that patients taking methotrexate for their arthritis seem to have less of the diseases caused by clogging of the arteries. The objective of this study is to find out if giving methotrexate at low doses to people with heart disease will prevent a second heart attack or stroke. This trial will be conducted in the US and Canada and aims at enrolling 7000 patients. Before randomization, the patients will be given a small dose (5mg/ week) of the drug for 5 weeks to confirm their tolerability to the medication. Only those who qualify will be enrolled, randomized and given either 15-20 mg of the drug or placebo each week for dash months. For the first six months visits will be scheduled at least once every month following which bi-monthly evaluations will be done.