CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,786 enrolled
Drug / intervention
Methotrexate +1 moredrug
Likely dose
Methotrexate 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01594333
NCT01594333Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate (LDM) in the Prevention of Cardiovascular Events Among Stable Coronary Artery Disease Patients With Type 2 Diabetes or Metabolic Syndrome

Brigham and Women's Hospital·interventional·Posted May 9, 2012·Updated Jul 24, 2020

In Brief

A Phase 3 clinical trial evaluating Methotrexate and Placebo for Cardiovascular Disease. Completed, enrolled 4,786 participants across 470 sites in 3 countries.

Detailed Summary

The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiovascular Disease
CountriesCanada, Puerto Rico, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 9, 2012
Enrollment StartApr 1, 2013
Primary CompletionApr 15, 2019
Study CompletionOct 30, 2019
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 14.1 years ago

Interventions

Methotrexatedrug

Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week

Placebodrug

Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week