August 22nd, 2012
NHLBI Announces 7000-Patient Trial to Test Inflammation Hypothesis
Larry Husten, PHD
The National Heart, Lung, and Blood Institute (NHLBI) has announced the launch of a large clinical trial testing the inflammation hypothesis. Paul Ridker is the principal investigator of the trial, which will be known as the Cardiovascular Inflammation Reduction Trial (CIRT).
CIRT will enroll 7,000 patients who are stable following a heart attack but are at high risk for a recurrent event because they have either type 2 diabetes or metabolic syndrome. Trial subjects will be randomized to low-dose methotrexate or placebo. The primary outcome measure is the rate of recurrent major cardiovascular events (MI, stroke, or cardiovascular death). Low-dose methotrexate is now used to treat rheumatoid arthritis.
“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,” said Ridker, in an NHLBI press release.
The NHLBI said that site selection will begin in November 2012 and that patient recruitment will start in March 2013. Patients will be followed for an average of 2.5 years.
Resources:
- CIRT on the ClinicalTrials.Gov website
- CIRT website (including information for potential sites)
- NHLBI press release
One Response to “NHLBI Announces 7000-Patient Trial to Test Inflammation Hypothesis”
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I am not sure that a positive result would necessarily be linked to an “anti-inflammatory” effect, as methotrexate can promote reverse cholesterol transport by upregulating the Tangier’s receptor(?ABC1A), an effect presumably mediated by the adenosine A2a receptor.
There is data supporting a positive effect on CV outcomes among patients with RA. Hopefully there will be no hepatotoxicity with potent statins on board.