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NIH trial to examine use of methotrexate for prevention of CVD
Researchers have launched an international, multisite trial to determine whether methotrexate can reduce cardiovascular disease that results in myocardial infarctions, strokes and deaths in patients at the highest risk, according to an NIH press release.
The NIH-funded Cardiovascular Inflammation Reduction Trial (CIRT) will be led by Paul Ridker, MD, MPH, the Eugene Braunwald professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention, a translational research unit at the Brigham and Women’s Hospital, and colleagues.
“If this generic drug, which is already on the market at low cost, proves effective for reducing risk of heart attacks, stroke or death, it has the potential for broad public health impact in saving lives and reducing disease,” Ridker said.
In November, the CIRT researchers will begin site selection of 350 to 400 sites within the United States and Canada. Patient recruitment will begin in March, with an eventual patient enrollment of 7,000 adults aged 18 years and older; they will be followed for 2 to 4 years. The estimated primary completion date is December 2016, and the estimated study completion date is December 2017.
Patients who experience no adverse effects during a 5-week testing period will be randomly assigned to standard care plus placebo or standard card plus low-dose methotrexate, according to the press release. Additionally, patients will take folic acid to prevent vitamin deficiencies.
The primary outcome measures will determine the rate of recurrent major CV events. The secondary outcomes measures will determine whether low-dose methotrexate will reduce all-cause mortality and certain heart- and blood vessel-related conditions and events (ie, incident deep vein thrombosis, pulmonary embolism, atrial fibrillation, hospitalization for chest pain or congestive heart failure, nonsurgical procedures or coronary artery bypass surgery, and newly diagnosed type 2 diabetes).
“This trial could have global impact by potentially changing treatment recommendations for millions of individuals with heart disease,” Gary H. Gibbons, MD, director of the National Heart, Lung, and Blood Institute, said in the release.
Disclosure: CIRT is funded by the NHLBI grants 1 U01 HL101422-01A1 (Clinical Coordinating Center) and 1 U01 HL101389-01A1 (Data Coordinating Center). Dr. Ridker has served as a consultant for various entities, receives additional research grant support from Novartis, and holds patents held by the Brigham and Women’s Hospital, which have been licensed to Siemens and AstraZeneca.