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Trial to Test Cardiac Potential of Anti-Inflammatory Drug



A clinical trial led by Brigham and Women’s Hospital in Boston will test the ability of a common anti-inflammatory drug to reduce rates of heart disease in high-risk patients. The trial is funded by grants from National Heart, Lung, and Blood Institute, part of National Institutes of Health.

Over 2 million people in the United States have heart attacks or strokes each year, causing death in many cases. Inflammation, along with high blood pressure and high cholesterol, plays a major role in heart attack and stroke. People who are obese, or have type 2 diabetes or metabolic syndrome often have elevated blood levels of various markers of inflammation and are at a higher risk of heart attack and stroke.

The Cardiovascular Inflammation Reduction Trial (CIRT) will test whether low-dose methotrexate, marketed as a generic drug by Teva Pharmaceuticals, can reduce the rates of recurrent cardiovascular events among patients with a prior heart attack, who also have diabetes or metabolic syndrome. Methotrexate is an inexpensive drug widely used to treat rheumatoid arthritis.

Researchers led by principal investigator Paul Ridker of Brigham and Women’s Hospital, will enroll 7,000 patients from up to 400 sites in the U.S. and Canada. Participants who tolerate the drug without side effects over a five-week test period will be randomly assigned to receive standard care plus a placebo, or standard care plus low-dose methotrexate. Patients in the trial will also take folic acid, which is routinely given with methotrexate to prevent vitamin deficiencies.

The trial will track participants for two to four years. During that time, researchers will document the number of strokes, heart attacks, and heart-related deaths among participants, as well as  death from all causes and certain heart- and blood vessel-related conditions and events. Those conditions and events include incident deep vein thrombosis, pulmonary embolism, atrial fibrillation, hospitalization for chest pain or congestive heart failure, non-surgical procedures or coronary artery bypass surgery, and newly diagnosed type 2 diabetes.

Researchers are also expected to establish blood and DNA banks to to study the effect of low-dose methotrexate on a number of inflammatory biomarkers. Screening is scheduled begin in January 2013 with patient recruitment starting in in March 2013.

“This new study is the end-game for more than fifteen years of research by investigators worldwide demonstrating that inflammation is a central part of the process that leads to heart attack and stroke,” says Ridker. “Whether or not reducing that inflammation can benefit our patients is unknown, but a positive finding in this trial has the potential to dramatically reshape how we think about and treat heart disease.”

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