A US research institute has put an early stop to a large trial investigating whether taking low-dose methotrexate could prevent heart attacks, strokes, or death in people with prior MI and either type 2 diabetes or the metabolic syndrome.
The halting of the large Cardiovascular Inflammation Reduction (CIRT) Trial. by the National Heart, Lung and Blood Institute (NHLBI) was based on a recommendation from the trial’s Data and Safety Monitoring Board. The action was not based on any substantive safety concerns.
“Sometime in late March or early April the NHLBI informed me that there were no substantive safety concerns but that the trial had accrued enough data to answer the main question of the study,” said Paul Ridker (Brigham & Women’s Hospital), the trial’s Principal Investigator.
CIRT was designed to test the inflammatory hypothesis by randomizing 7,000 patients with prior MI and either type 2 diabetes or metabolic syndrome to low dose methotrexate or placebo for 3-5 years.
The primary endpoint of CIRT was the composite of nonfatal MI, nonfatal stroke, and cardiovascular death.
Interest in the inflammatory hypothesis was heightened last year with the publication of the CANTOS trial, also headed by Paul Ridker, which demonstrated the beneficial effects of a different anti-inflammatory agent, canakinumab.
Ridker said the trial was stopped after 4,786 patients of the planned 7,000 patients had been enrolled. He said the investigators are now working to close out the study as fast as possible. “If all goes well we will present the results at the AHA in November,” he said.
Ridker emphasised that patients who take low dose methotrexate for arthritis have no reason to be concerned.
This article has been republished from Larry’s blog CardioBrief as part of a licensing agreement between Everyday Health and the limbic.