History of Changes for Study: NCT01594333

Cardiovascular Inflammation Reduction Trial (CIRT)

Latest version (submitted July 23, 2020) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	May 7, 2012	None (earliest Version on record)
2	June 22, 2012	Study Status, Study Design and Study Description
3	November 14, 2012	Study Status, Eligibility, Outcome Measures, Arms and Interventions, Study Description, Oversight and Study Identification
4	February 8, 2013	Study Status
5	April 4, 2013	Recruitment Status, Outcome Measures, Study Status, Contacts/Locations, Eligibility, Study Description and Oversight
6	April 11, 2013	Contacts/Locations and Study Status
7	July 30, 2013	Study Status and Study Identification
8	November 11, 2013	Outcome Measures, Study Description, Contacts/Locations, Eligibility, Study Status and Study Identification
9	July 16, 2014	Contacts/Locations and Study Status
10	November 21, 2014	Contacts/Locations, Study Status, Eligibility and Study Description
11	June 3, 2015	Contacts/Locations and Study Status
12	November 13, 2015	Contacts/Locations and Study Status
13	March 15, 2016	Study Status
14	May 23, 2016	Contacts/Locations and Study Status
15	May 24, 2016	Study Status
16	November 28, 2016	Contacts/Locations and Study Status
17	July 11, 2017	Contacts/Locations and Study Status
18	August 22, 2017	Contacts/Locations and Study Status
19	March 12, 2018	Contacts/Locations and Study Status
20	April 3, 2018	Recruitment Status, Contacts/Locations and Study Status
21	July 11, 2019	Recruitment Status, Study Status, Study Design
	Results Submission Events
June 20, 2020		Returned after QC review: July 8, 2020
22	July 23, 2020	Study Status, Outcome Measures, Contacts/Locations, Document Section, Results, Eligibility and Arms and Interventions

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Study NCT01594333
Submitted Date: May 7, 2012 (v1)

Study Identification


Unique Protocol ID:	Pending
Brief Title:	Cardiovascular Inflammation Reduction Trial (CIRT)
Official Title:	A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate (LDM) in the Prevention of Recurrent Cardiovascular Events Among Stable Post-myocardial Infarction Patients With Type 2 Diabetes or Metabolic Syndrome
Secondary IDs:	U01HL101422 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	May 2012
Overall Status:	Not yet recruiting
Study Start:	October 2012
Primary Completion:	December 2016 [Anticipated]
Study Completion:	December 2017 [Anticipated]

First Submitted:	May 1, 2012
First Submitted that Met QC Criteria:	May 7, 2012
First Posted:	May 9, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	May 7, 2012
Last Update Posted:	May 9, 2012 [Estimate]

Sponsor/Collaborators


Sponsor:	Brigham and Women's Hospital
Responsible Party:	Principal Investigator Investigator: Paul Ridker Official Title: Director, Center for Cardiovascular Disease and Prevention, Brigham and Women's Hospital Affiliation: Brigham and Women's Hospital
Collaborators:	National Heart, Lung, and Blood Institute (NHLBI)

Study Description


Brief 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.
Detailed Description:

Conditions


Conditions:	Cardiovascular Disease
Keywords:	Myocardial Infarction Stroke Cardiovascular death Type 2 Diabetes Metabolic Syndrome Cardiovascular Inflammation Atherothrombosis

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 4
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	7000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Methotrexate	Drug: Methotrexate Tablet, Oral, Target dose 20 mg weekly plus 1.2 mg folate 6 days/week Other Names: Trexall, TEVA Inc (brand of methotrexate)
Placebo Comparator: Placebo	Drug: Placebo Tablet, Oral, weekly plus 1.2 mg folate 6 days/week

Outcome Measures


Primary Outcome Measures:
1.	Rate of recurrent major cardiovascular events [ Time Frame: Four years ] Investigate whether low-dose methotrexate (LDM) will reduce rates of recurrent myocardial infarction, stroke, and cardiovascular death among stable post-myocardial infarction patients with type 2 diabetes or metabolic syndrome.
Secondary Outcome Measures:
1.	Rate of all-cause mortality [ Time Frame: Four years ]
2.	Rate of hospitalization for congestive heart failure [ Time Frame: Four years ]
3.	Rate of incident venous thromboembolism [ Time Frame: Four years ]
4.	Rate of atrial fibrillation [ Time Frame: Four years ]
5.	Rate of percutaneous or surgical coronary revascularization [ Time Frame: Four years ]
6.	Rate of incident diabetes among those without diabetes at randomization [ Time Frame: Four years ]

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Documented myocardial infarction within the past five years AND Type 2 diabetes OR metabolic syndrome Completed any planned coronary revascularization procedures Medically stable for at least 60 days prior to screening Age ≥ 18 years at screening Exclusion Criteria: Chronic liver disease Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease Chronic infectious disease Chronic pulmonary disease, such as COPD/emphysema, interstitial lung disease or pulmonary fibrosis Myeloproliferative disease in past 5 years HIV positive Requirement for, or intolerance to, methotrexate or folate History of non-basal cell malignancy or treatment for lymphoproliferative disease in past 5 yr Requirement for use of drugs that alter folate metabolism History of alcohol abuse or unwillingness to limit consumption to ≤ 3 drinks per week Woman of childbearing potential (even if using oral contraceptive agents) or intention to breastfeed Men who plan to father children during the study period or are unwilling to use barrier methods of contraception Life expectancy < 3 years or unlikely to comply in judgment of investigator Chronic use of oral or IV steroid therapy or other immunosuppressive or biologic response modifiers (see drug list in Manual of Operations) History of hepatitis B or C Chronic pericardial effusion, pleural effusion or ascites New York Heart Association Class IV heart failure

Contacts/Locations


Central Contact Person:	CIRT Study Information Telephone: 855-437-9330
Study Officials:	Paul Ridker, MD, MPH Principal Investigator Brigham and Women's Hospital
Locations:

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