Cardiovascular Inflammation Reduction Trial (CIRT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Brigham and Women's Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paul Ridker, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01594333
First received: May 1, 2012
Last updated: July 16, 2014
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Cardiovascular Disease
Drug: Methotrexate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Rate of major cardiovascular events [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
    Investigate whether 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.


Secondary Outcome Measures:
  • Rate of all-cause mortality [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of the primary endpoint plus coronary revascularization [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of hospitalization for congestive heart failure [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of primary endpoint plus all-cause mortality plus coronary revascularization plus congestive heart failure [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of new onset type 2 diabetes among those with metabolic syndrome but not diabetes at study entry [ Time Frame: Up to six years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Rate of the primary endpoint plus unstable angina requiring unplanned coronary revascularization [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of coronary revascularization [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of peripheral artery disease [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of symptomatic deep vein thrombosis or pulmonary embolism, including those considered to be provoked and those considered to be idiopathic [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of clinically significant aortic stenosis [ Time Frame: Up to six years ] [ Designated as safety issue: No ]
  • Rate of atrial fibrillation [ Time Frame: Up to six years ] [ Designated as safety issue: No ]

Estimated Enrollment: 7000
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate Drug: Methotrexate
Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
Other Name: Trexall, TEVA Inc (brand of methotrexate)
Placebo Comparator: Placebo Drug: Placebo
Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week

Detailed Description:

While inflammation contributes crucially to atherothrombosis, it is unknown whether inhibition of inflammation per se will lower vascular event rates. The primary aim of the Cardiovascular Inflammation Reduction Trial (CIRT) is to directly test 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 randomized, double-blind, placebo-controlled, multi-center, event-driven trial that will randomize 7,000 men and women from the United States and Canada. Following a five- to six-week open-label run-in (maximum 8 weeks), eligible participants who have either suffered documented myocardial infarction in the past 5 years or have angiographically demonstrated multivessel coronary artery disease in the past five years will be randomly allocated over a three to four year period to usual care plus placebo or usual care plus LDM. 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. All study participants will additionally receive 1.0 mg oral folate to be taken daily six days per week. LDM complications will be minimized through education programs for all investigators and coordinators, through enhanced communication with study participants, by limiting enrollment to those with no evidence of malignancy, hepatitis, renal dysfunction, chronic infection, pulmonary disease, or other risk factors for toxicity; by conducting an initial 5- to 6-week active-therapy run-in (maximum 8 weeks) designed to eliminate individuals who are either intolerant of or unable to adhere to treatment before randomization; and through regular monitoring of liver function and hematologic indices using a centralized methodology designed to ensure participant safety, allow for dose adjustments while maintaining the study blind, and provide an efficient method to address issues of compliance and follow-up on a cost-effective centralized basis. The primary trial endpoint is the rate of myocardial infarction, stroke, or cardiovascular death. Secondary and tertiary endpoints include all-cause mortality, coronary revascularization, incident congestive heart failure, incident peripheral artery disease, incident venous thrombosis, clinically significant aortic stenosis, incident atrial fibrillation, incident diabetes among those with metabolic syndrome but not diabetes at study entry, and hemoglobin A1c (HbA1c) control among those with diabetes at study entry. 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. The potential clinical impact of CIRT is broad as it has sufficient power to directly address core issues in the inflammatory hypothesis of atherothrombosis, and thus, if successful, will open major new directions for cardiovascular treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years at screening
  • Documented myocardial infarction within the past five years OR evidence of multivessel coronary artery disease by angiography in the past 5 years.

    • To qualify on the basis of a myocardial infarction in the past 5 years, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.
    • To qualify on the basis of multivessel coronary disease, there must be angiographic evidence within the past 5 years of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.
  • History of type 2 diabetes or metabolic syndrome at time of study enrollment
  • Willingness to participate as evidenced by signing the study informed consent

Exclusion Criteria:

  • Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of < 3 years;
  • Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
  • White blood cell count < 3,500/ul, hematocrit < 32 percent, or platelet count < 75,000/ul
  • Liver transaminase levels (AST or ALT) >upper limit of normal (ULN) or albumin < the lower limit of normal (LLN);
  • Creatinine clearance < 40 ml/min as estimated with the Cockroft-Gault equation;
  • History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
  • Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed.
  • Men who plan to father children during the study period or who are unwilling to use effective forms of contraception.
  • Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible;
  • Current indication for methotrexate therapy;
  • Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions.
  • Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol.
  • New York Heart Association Class IV congestive heart failure.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594333

Contacts
Contact: CIRT Study Information 855-437-9330

  Hide Study Locations
Locations
United States, Alabama
Adamsville Family Medicine Recruiting
Adamsville, Alabama, United States, 35005
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35294
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Saadat Ansari MD LLC Recruiting
Huntsville, Alabama, United States, 35801
University of South Alabama: Division of Clinical Research Recruiting
Mobile, Alabama, United States, 36617
United States, Arizona
Arizona Arthritis & Rheumatology Associates, PC Recruiting
Phoenix, Arizona, United States, 85032
Maricopa Integrated Health System Recruiting
Phoenix, Arizona, United States, 85008
Scottsdale Medical Imaging Recruiting
Scottsdale, Arizona, United States, 85258
The Heart Clinic Recruiting
Scottsdale, Arizona, United States, 85258
United States, Arkansas
Michael A. Frais, Cardiologist, P.A. Recruiting
Hot Springs, Arkansas, United States, 71913
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
Arkansas Cardiology Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Ram Dandillaya MD, Inc. Recruiting
Beverly Hills, California, United States, 90211
Medical Group of Culver City Recruiting
Culver City, California, United States, 90230
Touro University California- Solano County Affiliated Clinics Recruiting
Fairfield, California, United States, 94533
Kumar Medical Corporation Recruiting
Lancaster, California, United States, 93534
Los Alamitos Cardiovascular Recruiting
Los Alamitos, California, United States, 90720
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Shervin Eshaghian M.D., Inc. (Beverly Hills Cardiology) Recruiting
Los Angeles, California, United States, 90067
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90017
Anthony Mills M.D., Inc. Recruiting
Los Angeles, California, United States, 90096
Central Coast Cardiology Recruiting
Monterey, California, United States, 93940
Spectrum Clinical Research Institute, Inc. Recruiting
Moreno Valley, California, United States, 92553
Albert Sharf, MD Recruiting
National City, California, United States, 91950
University of CA Irvine Medical Center Recruiting
Orange, California, United States, 92868
Huntington Memorial Hospital Recruiting
Pasadena, California, United States, 91105
Arroya Medical Group Recruiting
Pismo Beach, California, United States, 93449
Central Coast Cardiology Recruiting
Salinas, California, United States, 93901
Ritchken and First MDs Recruiting
San Diego, California, United States, 92117
Foundation for Cardiovascular Medicine Recruiting
San Diego, California, United States, 92121
Veterans Affairs San Diego Healthcare System Recruiting
San Diego, California, United States, 92161
San Diego Cardiac Center Recruiting
San Diego, California, United States, 92123
Coastal Heart Medical Group, Inc. Recruiting
Santa Ana, California, United States, 92704
Comprehensive Cardiovascular Care Recruiting
Santa Maria, California, United States, 93454
Pacific Heart and Vascular Medical Group Recruiting
Stockton, California, United States, 95210
Manoj D. Aswani M.D. Recruiting
Thousand Oaks, California, United States, 91360
Touro University California- Solano Public Health Affiliated Clinics Recruiting
Vallejo, California, United States, 94592
Shiva Heart Center Recruiting
Wildomar, California, United States, 92595
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Connecticut Heart and Vascular Center Recruiting
Bridgeport, Connecticut, United States, 06606
United States, District of Columbia
Boisey Barnes MD, PC Recruiting
Washington, District of Columbia, United States, 20024
United States, Florida
Florida Lung, Asthma and Sleep Specialists Recruiting
Celebration, Florida, United States, 32747
Steven Cohen MD Recruiting
Delray Beach, Florida, United States, 33484
Continental Research Corp Recruiting
Doral, Florida, United States, 33126
The Cardiac and Vascular Institute Recruiting
Gainesville, Florida, United States, 32605
University of Florida Recruiting
Gainesville, Florida, United States, 32610
State of the Art Research Recruiting
Hialeah, Florida, United States, 33010
Best Quality Research, Inc. Recruiting
Hialeah, Florida, United States, 33016
South Florida Research Solutions, LLC Recruiting
Hollywood, Florida, United States, 33021
Florida Heart & Vascular Center: Leesburg Recruiting
Leesburg, Florida, United States, 34748
A.M. Medical Center & Research Recruiting
Miami, Florida, United States, 33165
Cardiovascular Research Center of South Florida Recruiting
Miami, Florida, United States, 33173
St. Paul Medical Research Center, Inc. Recruiting
Miami, Florida, United States, 33126
Life Spring Research Foundation Recruiting
Miami, Florida, United States, 33134
Veritas Research Corp. Recruiting
Miami Lakes, Florida, United States, 33014
Ocean Blue Medical Research Center Recruiting
Miami Springs, Florida, United States, 33166
Southwest Florida Research, LLC Recruiting
Naples, Florida, United States, 34102
Edgewater Medical Research, Inc. Recruiting
New Smyma Beach, Florida, United States, 32169
Pharma Research International, Inc. Recruiting
South Miami, Florida, United States, 33143
Bay Area Heart Center: 49th Street Recruiting
St. Petersburg, Florida, United States, 33705
Bay Area Heart Center: 7th Avenue Recruiting
St. Petersburg, Florida, United States, 33705
Florida Heart & Vascular Center Recruiting
The Villages, Florida, United States, 32159
United States, Georgia
Athens Regional Medical Center Recruiting
Athens, Georgia, United States, 30606
Synergy Therapeutic Partners Recruiting
Atlanta, Georgia, United States, 30308
Atlanta Veterans Affairs Medical Center Recruiting
Atlanta, Georgia, United States, 30033
Rockdale Medical Research Associates Recruiting
Conyers, Georgia, United States, 30094
Atlanta Heart Specialists, LLC Recruiting
Cumming, Georgia, United States, 30041
Heart and Rhythm Specialists Recruiting
Dalton, Georgia, United States, 30720
Albert F. Johary MD, PC Recruiting
Dunwoody, Georgia, United States, 30338
Atlanta Vanguard Medical Associates Recruiting
Smyrna, Georgia, United States, 30082
Atlanta Heart Specialists, LLC Recruiting
Tucker, Georgia, United States, 30084
United States, Idaho
St. Luke's Idaho Cardiology Associates Recruiting
Boise, Idaho, United States, 83712
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
United States, Illinois
Northwest Heart Clinical Research Recruiting
Arlington Heights, Illinois, United States, 60005
Advocate Med Group-Heart & Vascular Of Illinois Recruiting
Chicago, Illinois, United States, 60657
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Tien C. Cheng Recruiting
Gurnee, Illinois, United States, 60031
Illinois Heart & Lung Research Center, SC Recruiting
Normal, Illinois, United States, 61761
United States, Indiana
Cardiospecialists, LTD Recruiting
Dyer, Indiana, United States, 46311
Indiana Heart Physicians Recruiting
Indianapolis, Indiana, United States, 46237
The Heart Center of Lake County Recruiting
Merriville, Indiana, United States, 46410
Medical Consultants, PC Recruiting
Muncie, Indiana, United States, 47303
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
United States, Kentucky
Krishnan Challappa M.D. PSC Recruiting
Elizabethtown, Kentucky, United States, 42701
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Research Integrity LLC Recruiting
Owensboro, Kentucky, United States, 42303
United States, Louisiana
Grace Research, LLC Recruiting
Bossier City, Louisiana, United States, 71111
Dorothy H. Banish, MD, APMC Study Group Recruiting
Covington, Louisiana, United States, 70433
American Clinical Research, LLC Recruiting
Marrero, Louisiana, United States, 70072
Otis Barnum D.O.P.C. Recruiting
Natchitoches, Louisiana, United States, 71457
Tulane University Office of Health Research Recruiting
New Orleans, Louisiana, United States, 70112
Veterans Affairs Medical Center Shreveport Recruiting
Shreveport, Louisiana, United States, 71101
United States, Maine
Maine Research Associates Recruiting
Auburn, Maine, United States, 04210
Paul A. Shapero, M.D. Recruiting
Bangor, Maine, United States, 04401
Maine Medical Partners Maine Health Cardiology Recruiting
South Portland, Maine, United States, 04106
Maine Centers for Healthcare Recruiting
Westbrook, Maine, United States, 04092
United States, Maryland
Cardiac Consultants, LLC Recruiting
Annapolis, Maryland, United States, 21401
St. Mary's Medical Center Recruiting
Charlotte Hall, Maryland, United States, 20622
Calvert Memorial Hospital Recruiting
Clinton, Maryland, United States, 20735
Phillip J. Bean Medical Center Recruiting
Hollywood, Maryland, United States, 20636
Shah Associates, MD, LLC Recruiting
Prince Frederick, Maryland, United States, 20678
Peninsula Cardiology Associates Recruiting
Salisbury, Maryland, United States, 21804
Washington Adventist Hospital Recruiting
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
MGH Cardiology Recruiting
Boston, Massachusetts, United States, 02214
Joslin Diabetes Center Recruiting
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital - Chelsea Health Care Center Recruiting
Chelsea, Massachusetts, United States, 02150
Pentucket Medical Associates, Inc. Recruiting
Haverhill, Massachusetts, United States, 01830
South Shore Internal Medicine Recruiting
Milton, Massachusetts, United States, 02186
Charles River Medical Associates Recruiting
Natick, Massachusetts, United States, 01760
Lahey Medical Center Recruiting
Peabody, Massachusetts, United States, 02149
North Shore Cardiovascular Associates Recruiting
Salem, Massachusetts, United States, 01907
United States, Michigan
Endeavor Medical Research Recruiting
Alpena, Michigan, United States, 49707
John D. Dingell Veterans Affairs Medical Center Recruiting
Detroit, Michigan, United States, 48201
Harris & Associates, PC Recruiting
Detroit, Michigan, United States, 48235
Trace Research Group at Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Apex Medical Research MI, Inc. Recruiting
Flint, Michigan, United States, 48504
Garden City Hospital Recruiting
Garden City, Michigan, United States, 48135
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Detroit Clinical Research Center, PC Recruiting
Livonia, Michigan, United States, 48154
Academic Cardiology Associates PC Recruiting
Rochester Hills, Michigan, United States, 48307
Beaumont Health Center Recruiting
Royal Oak, Michigan, United States, 48073
Covenant Medical Center, Inc. Recruiting
Saginaw, Michigan, United States, 48602
United States, Minnesota
United Heart and Vascular Clinic Recruiting
Saint Paul, Minnesota, United States, 55102
Centra Care Heart & Vascular Center at St. Cloud Hospital Recruiting
St. Cloud, Minnesota, United States, 56303
United States, Mississippi
Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39402
David M. Headley M.D. PA Planters Clinic Recruiting
Port Gibson, Mississippi, United States, 39150
Stern Cardiovascular Foundation, Inc. Recruiting
Southaven, Mississippi, United States, 38671
United States, Missouri
Clinical Research Center University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Quantum Research LLC Recruiting
Festus, Missouri, United States, 63028
Midwest Cardiology Associates Recruiting
Independence, Missouri, United States, 64057
Freeman Health System Recruiting
Joplin, Missouri, United States, 64804
Midwest Heart and Vascular Specialists Recruiting
Kansas City, Missouri, United States, 64132
Saint Luke's Lipid & Diabetes Research Recruiting
Kansas City, Missouri, United States, 64111
The Kansas City Free Health Clinic Recruiting
Kansas City, Missouri, United States, 64111
VA Medical Center Kansas City Recruiting
Kansas City, Missouri, United States, 64128
Lake Regional Cardiovascular Institute Recruiting
Osage Beach, Missouri, United States, 65065
CoxHealth: Wheeler Heart & Vascular Center Recruiting
Springfield, Missouri, United States, 65807
Consult and Research Associates Recruiting
St. Louis, Missouri, United States, 63122
United States, Montana
Great Falls Clinic Clinical Research Deptartment Recruiting
Great Falls, Montana, United States, 59420
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Heart Consultants Recruiting
Omaha, Nebraska, United States, 68114
United States, Nevada
Accent Clinical Trials Recruiting
Las Vegas, Nevada, United States, 89106
Impact Clinical Trials Recruiting
Las Vegas, Nevada, United States, 89106
Renown Inst for Heart & Vasc Health Recruiting
Reno, Nevada, United States, 89503
United States, New Hampshire
Lahey Cardiology Recruiting
Nashua, New Hampshire, United States, 03060
United States, New Jersey
Family Health at Mount Olive Recruiting
Flanders, New Jersey, United States, 07836
Cardiocare Recruiting
Hillsborough, New Jersey, United States, 08844
Total Cardiology Care, LLC Recruiting
Jersey City, New Jersey, United States, 07307
Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Cardiovascular Institute Recruiting
New Brunswick, New Jersey, United States, 08901
Cardio Metabolic Institute Recruiting
Somerset, New Jersey, United States, 08873
Shore Health Group Recruiting
Toms River, New Jersey, United States, 08753
Total Cardiology Care, LLC Recruiting
Wayne, New Jersey, United States, 07470
Westwood Cardiology Associates Recruiting
Westwood, New Jersey, United States, 07675
United States, New York
Buffalo Heart Group Recruiting
Buffalo, New York, United States, 14215
Bassett Healthcare Network Recruiting
Cooperstown, New York, United States, 13326
NYU Hudson Valley Cardiology Recruiting
Cortlandt Manor, New York, United States, 10567
NYHQ Recruiting
Flushing, New York, United States, 11355
Jamaica Hospital Medical Center Recruiting
Jamaica, New York, United States, 11418
ProHealth Care Associates Recruiting
Lake Success, New York, United States, 11042
Long Island Cardiovascular Consultants Recruiting
Manhasset, New York, United States, 11758
Long Island Heart Associates Recruiting
Mineola, New York, United States, 11501
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11040
Queens Long Island Medical Group Recruiting
New Hyde Park, New York, United States, 11577
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Chinatown Cardiology, PC Recruiting
New York, New York, United States, 10013
Associate In Internal Medicine Practice Recruiting
New York, New York, United States, 10032
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Axis Clinical Trials Recruiting
New York, New York, United States, 10018
DiGiovanna Institute for Medical Education and Research Recruiting
North Massapequa, New York, United States, 11758
Champlain Valley Physician Hospital Recruiting
Plattsburgh, New York, United States, 12901
United States, North Carolina
Metrolina Internal Medicine Recruiting
Charlotte, North Carolina, United States, 28204
Gaffney Health Services Recruiting
Charlotte, North Carolina, United States, 28205
Eastern Carolina Cardiovascular, PA Recruiting
Elizabeth City, North Carolina, United States, 27909
Eastern Cardiology Recruiting
Greenville, North Carolina, United States, 27834
Northside Clinical Research Recruiting
Lenoir, North Carolina, United States, 28645
Cardiology Associates of Carolinas, PA Recruiting
Morganton, North Carolina, United States, 28655
Eastern Nephrology Associates, PLLC Recruiting
New Bern, North Carolina, United States, 28562
Boice Willis Clinic Recruiting
Rocky Mount, North Carolina, United States, 27804
Sanford Cardiology Recruiting
Sanford, North Carolina, United States, 27330
Natalie A. Doyle, MD, PA Recruiting
Wilson, North Carolina, United States, 27893
United States, Ohio
Ohio University Heritage College of Osteopathic Medicine Recruiting
Athens, Ohio, United States, 45701
Dayton Veteran Affairs Medical Center Recruiting
Dayton, Ohio, United States, 45428
Dayton Heart Center Recruiting
Dayton, Ohio, United States, 45414
Colonnade Medical Group Recruiting
Lancaster, Ohio, United States, 43130
Middletown Cardiovascular Associates Recruiting
Middletown, Ohio, United States, 45044
Apex Medical Research, Inc. Recruiting
Springfield, Ohio, United States, 45505
Comprehensive Heart Care, Inc. Recruiting
Toledo, Ohio, United States, 43606
Mount Carmel Clinical Cardiovascular Care Recruiting
Westerville, Ohio, United States, 43081
Wooster Heart Group Recruiting
Wooster, Ohio, United States, 44691
United States, Oklahoma
COR Clinical Research, LLC Recruiting
Oklahoma City, Oklahoma, United States, 73103
Oklahoma State University Center for Health Sciences Recruiting
Tulsa, Oklahoma, United States, 74127
United States, Oregon
Samaritan Health Services Recruiting
Corvallis, Oregon, United States, 97330
Southern Oregon Cardiology, LLC Recruiting
Medford, Oregon, United States, 97504
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's University Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18018
Spirit Physician Services, Inc Recruiting
Camp Hill, Pennsylvania, United States, 17011
The Chambersburg Hospital Recruiting
Chambersburg, Pennsylvania, United States, 17201
Central Bucks Cardiology Recruiting
Doylestown, Pennsylvania, United States, 18901
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Gadani Associates Recruiting
Enola, Pennsylvania, United States, 17025
Heart Specialists of Lancaster County Recruiting
Ephrata, Pennsylvania, United States, 17522
Saint Vincent Consultants in Cardiovascular Diseases, LLC Recruiting
Erie, Pennsylvania, United States, 16502
Christiana Care Health System Recruiting
Glen Mills, Pennsylvania, United States, 19342
Pinnacle Health Cardiovascular Institute Recruiting
Harrisburg, Pennsylvania, United States, 17110
Lycoming Internal Medicine, Inc. Recruiting
Jersey Shore, Pennsylvania, United States, 17740
Bucks County Clinical Research Recruiting
Morrisville, Pennsylvania, United States, 19067
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Drexel University College of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19102
Lehigh Valley Health Services Recruiting
Sellersville, Pennsylvania, United States, 18960
Pish Medical Associates, Inc. Recruiting
Uniontown, Pennsylvania, United States, 15401
The Washington Hospital- Cardiovascular Consultants Recruiting
Washington, Pennsylvania, United States, 15301
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Lehigh Valley Family Practice Recruiting
Whitehall, Pennsylvania, United States, 18052
Jeffry A. Lindenbaum DO, PC Recruiting
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
United States, South Carolina
Marva D. Williams M.D. Recruiting
Manning, South Carolina, United States, 29102
Inlet Cardiopulmonary & Associates Recruiting
Pawleys Island, South Carolina, United States, 29585
United States, Tennessee
Stern Cardiovascular Foundation, Inc. Recruiting
Germantown, Tennessee, United States, 38138
Kore Cardiovascular Research Institutue Recruiting
Jackson, Tennessee, United States, 38305
Cardiovascular Research of Knoxville Recruiting
Knoxville, Tennessee, United States, 37917
Clinical Research Center Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
United States, Texas
Southeast TX Clinical Research Center Recruiting
Beaumont, Texas, United States, 77702
Texas Health Physicians Group Recruiting
Carrollton, Texas, United States, 75010
North Texas Health Center Recruiting
Dallas, Texas, United States, 75231
Dallas VA Medical Center Recruiting
Dallas, Texas, United States, 75216
The Heart Center of Dallas Recruiting
Dallas, Texas, United States, 75235
The Medical Group of Texas Recruiting
Fort Worth, Texas, United States, 76104
Texas Health Physicians Group Recruiting
Fort Worth, Texas, United States, 76107
T&R Clinic, P.A. Recruiting
Haltom City, Texas, United States, 76117
Michele P. Sartori, MD Recruiting
Houston, Texas, United States, 77030
Amcare Clinical Research, Inc. Recruiting
Houston, Texas, United States, 77090
Methodist Hospital San Antonio TX Recruiting
Live Oak, Texas, United States, 78233
Grace Research, LLC Recruiting
Marshall, Texas, United States, 75670
Valley Heart Consultants Recruiting
McAllen, Texas, United States, 78503
Heart Center, Palo Pinto General Hospital Recruiting
Mineral Wells, Texas, United States, 76067
Valley Central Research Inc Recruiting
Mission, Texas, United States, 78572
Medical Clinic of North Texas Recruiting
Plano, Texas, United States, 75023
Northwest Houston Clinical Research Recruiting
Tomball, Texas, United States, 77375
United States, Utah
Utah Diabetes Center Recruiting
Salt Lake City, Utah, United States, 84108
United States, Virginia
Virginia Cardiovascular Associates Recruiting
Manassas, Virginia, United States, 20109
Manassas Clinical Research Center Recruiting
Manassas, Virginia, United States, 20110
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Roanoke Heart Institute PLC Recruiting
Roanoke, Virginia, United States, 24014
Tidewater Physicians Multispecialty Group Recruiting
Yorktown, Virginia, United States, 23690
United States, Washington
Kootenai Heart Clinics, LLC Recruiting
Spokane, Washington, United States, 99204
Northwest Medical Associates, P.S. Recruiting
Vancouver, Washington, United States, 98684
United States, Wisconsin
Cardiology Associates of Bellin Health Recruiting
Green Bay, Wisconsin, United States, 54115
Dean Foundation Recruiting
Madison, Wisconsin, United States, 53715
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Canada, Ontario
Peel Research Associates Recruiting
Brampton, Ontario, Canada, L6W2X7
North Peel Family Health Team Recruiting
Brampton, Ontario, Canada, L6T 4S5
Brampton Research Associates Recruiting
Brampton, Ontario, Canada, L6Z 4N5
Aviva Clinical Trial Group, Inc Recruiting
Burlington, Ontario, Canada, L7M 4Y1
Vizel Cardiac Research Recruiting
Cambridge, Ontario, Canada, N1R7R1
Joanne F. Liutkus Medicine, PC Recruiting
Cambridge, Ontario, Canada, N1R7L6
Dr. William Liang Recruiting
Hamilton, Ontario, Canada, L8W3J6
Dr. Ronald Fowlis Recruiting
Kitchener, Ontario, Canada, N2M 5NG
University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Seva Cardiac Centre Recruiting
Markham, Ontario, Canada, L3R 1A3
Malton Medical Research Recruiting
Mississauga, Ontario, Canada, L4T 4J2
Newmarket Cardiology Research Group Recruiting
Newmarket, Ontario, Canada, L3Y 8C3
Portage Medical Centre Recruiting
Niagra Falls, Ontario, Canada, I2E6A6
Humber River Regional Hospital Recruiting
North York, Ontario, Canada, M3N2V6
Dr. James Y. Cha Recruiting
Oshawa, Ontario, Canada, L1J2K1
Kawartha Cardiology Clinical Trials Recruiting
Peterborough, Ontario, Canada, K9J0B2
Steeple Hill Medical Centre Recruiting
Pickering, Ontario, Canada, L1V 2A6
Milliken Medical Centre Recruiting
Scarborough, Ontario, Canada, M1V5P6
Scarborough General Hospital Cardiology Research Associates Recruiting
Scarborough, Ontario, Canada, M1PT27
Scarborough Cardiology Research Recruiting
Scarborough, Ontario, Canada, M1E5E9
Canadian Centre for Research on Diabetes Recruiting
Smith Falls, Ontario, Canada, K7A 4W8
Dr. R. Labonte Professional Med Corp Recruiting
Sudbury, Ontario, Canada, P3E 3B8
Sudbury Cardiac Research Recruiting
Sudbury, Ontario, Canada, P3E2N8
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Viacar Recherche Clinique Inc. Recruiting
Brossard, Quebec, Canada, J4X1S4
Viacar Recherche Clinique Inc. Recruiting
Greenfield Park, Quebec, Canada, J4V2G8
Canada
Recherche Clinique Sigma, Inc. Recruiting
Quebec, Canada, G1G3Z4
Puerto Rico
Edwin Camilo Vazquez, MD Recruiting
Aguas Buenas, Puerto Rico, 00703
Norma S. Severino-Pacheco, MD Recruiting
Canovanas, Puerto Rico, 00729
Limarys Cruz Ortiz MD Recruiting
Naranjito, Puerto Rico
Denis Ruiz-Serrano, MD Recruiting
Rio Grande, Puerto Rico
Yolanda Sierra Quinones, MD Recruiting
Toa Baja, Puerto Rico, 00949
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Paul Ridker, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided by Brigham and Women's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Ridker, Director, Center for Cardiovascular Disease and Prevention, Brigham and Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01594333     History of Changes
Other Study ID Numbers: 2012P-000857, U01HL101422, U01HL101389
Study First Received: May 1, 2012
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
United States: National Heart Lung and Blood Institute
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Brigham and Women's Hospital:
Myocardial Infarction
Stroke
Cardiovascular death
Type 2 Diabetes
Metabolic Syndrome
Cardiovascular Inflammation
Atherothrombosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014