Cardiovascular Inflammation Reduction Trial (CIRT) stopped early
The Cardiovascular Inflammation Reduction Trial (CIRT) has been stopped early by the National Heart, Lung, and Blood Institute (NHLBI) of the American National Institutes of Health, writes Larry Husten on the website Forbes, on May 21, 2018. He adds that the decision was based on a recommendation from the trial’s Data and Safety Monitoring Board, and not on any substantive safety concerns.
In the news article, Paul Ridker (Brigham and Women’s Hospital, Boston, MA, USA), CIRT’s Principal Investigator says that the NHLBI had informed him ‘that there were no substantive safety concerns but that the trial had accrued enough data to answer the main question of the study’.
CIRT was a randomized clinical that directly tests the inflammatory hypothesis of atherothrombosis by evaluating whether or not low-dose methotrexate (LDM) will reduce rates of myocardial infarction, stroke, and cardiovascular death among stable coronary artery disease patients with type 2 diabetes or metabolic syndrome, conditions associated with an enhanced pro-inflammatory response. CIRT is a double-blind, placebo-controlled, multi-center, event-driven trial that aimed to randomize 7,000 men and women from the United States and Canada. The target methotrexate dose among those allocated to active therapy is 15 to 20 mg po per week, a dose within the range of that commonly used for the treatment of rheumatoid arthritis.
The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. On clinicaltrials.gov, it is written that the trial is event driven such that in the absence of extreme effects, the trial will conclude after accrual of at least 530 primary endpoints, an effect estimated to provide 90 percent power to detect a 25 percent relative risk reduction.
On Forbes, Ridker said that the trial was stopped after enrollment of 4786 patients. He also emphasized that patients who take low dose methotrexate for arthritis have no reason to be concerned. The data may be presented during the American Heart Association Scientific Session in November, 2018.