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NIH Launches Study of Methotrexate for Prevention of Heart Attacks, Strokes, and Cardiovascular Deaths

Patient recruitment begins in March 2013 (Aug. 22)

The National Institutes of Health (NIH) announced on August 22 that a study has been launched to determine whether methotrexate, a commonly used anti-inflammatory drug, can reduce heart attacks, strokes, and deaths due to cardiovascular disease in people at high risk. The study is being supported by the National Heart, Lung, and Blood Institute (NHLBI), a part of the NIH.

Inflammation, along with high blood pressure and high cholesterol, plays a major role in heart attack and stroke.

The Cardiovascular Inflammation Reduction Trial (CIRT) will determine whether treatment with methotrexate reduces the rates of cardiovascular events among adults who have had a heart attack within the past 5 years and who also have type 2 diabetes or metabolic syndrome. The trial will randomly assign participants to receive methotrexate (10 to 20 mg weekly) or placebo for 3 to 4 years.

Methotrexate is an inexpensive generic drug commonly used at low doses to treat rheumatoid arthritis. It is also used at higher doses to treat certain forms of cancer, such as leukemias and lymphomas.

Adults who have type 2 diabetes are more likely to die of heart disease or stroke than are people without type 2 diabetes. Metabolic syndrome — a cluster of traits that includes a large waistline, high blood pressure, high levels of blood triglyceride, high blood sugar, and low blood high-density lipoprotein (HDL; the “good” cholesterol) — also increases the risk of heart attack and stroke. Many people with type 2 diabetes and obesity also have metabolic syndrome. People with diabetes or metabolic syndrome typically have elevated blood levels of various markers of inflammation.

The CIRT trial will enroll 7,000 patients at sites in the U.S. and Canada over the next 2.5 years and will follow the patients for 2 to 4 years. Site selection will begin in November 2012, and patient recruitment will begin in March 2013.

For more information, visit the NIH Web site.

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