CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

Who is this study for? Adult patients with atheroscleosis
What treatments are being studied? Metformin XR
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test.

• Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.

⁃ Coronary artery disease is fulfilled by at least one of (1), (2), or (3):

• History of myocardial infarction at least one month prior to randomization.

• History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.

• Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.

⁃ Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4):

• Documented prior ischemic stroke (at least one month prior to randomization),

• Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),

• Asymptomatic carotid stenosis of at least 70% luminal diameter,

• History of carotid revascularization (surgical or catheter-based).

⁃ Peripheral arterial disease: Fulfilled by at least one of the following:

• History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,

• Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.

⁃ 3\. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2.

⁃ 4\. Informed consent has been fully executed, and participant agrees to study procedures.

Locations
United States
Arkansas
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
RECRUITING
Little Rock
Arizona
Phoenix VA Health Care System, Phoenix, AZ
RECRUITING
Phoenix
Southern Arizona VA Health Care System, Tucson, AZ
RECRUITING
Tucson
California
VA Loma Linda Healthcare System, Loma Linda, CA
RECRUITING
Loma Linda
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
VA Palo Alto Health Care System, Palo Alto, CA
RECRUITING
Palo Alto
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
RECRUITING
West Los Angeles
Colorado
Rocky Mountain Regional VA Medical Center, Aurora, CO
RECRUITING
Aurora
Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
RECRUITING
West Haven
Florida
Bay Pines VA Healthcare System, Pay Pines, FL
RECRUITING
Bay Pines
North Florida/South Georgia Veterans Health System, Gainesville, FL
RECRUITING
Gainesville
Miami VA Healthcare System, Miami, FL
RECRUITING
Miami
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Hawaii
VA Pacific Islands Health Care System, Honolulu, HI
RECRUITING
Honolulu
Iowa
Iowa City VA Health Care System, Iowa City, IA
RECRUITING
Iowa City
Illinois
Jesse Brown VA Medical Center, Chicago, IL
TERMINATED
Chicago
Edward Hines Jr. VA Hospital, Hines, IL
RECRUITING
Hines
Kentucky
Lexington VA Medical Center, Lexington, KY
NOT_YET_RECRUITING
Lexington
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
RECRUITING
Boston
Maryland
Rehabilitation R&D Service, Baltimore, MD
RECRUITING
Baltimore
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
Missouri
Kansas City VA Medical Center, Kansas City, MO
RECRUITING
Kansas City
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
Nebraska
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
RECRUITING
Omaha
New Mexico
New Mexico VA Health Care System, Albuquerque, NM
RECRUITING
Albuquerque
New York
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
RECRUITING
New York
Ohio
Cincinnati VA Medical Center, Cincinnati, OH
ACTIVE_NOT_RECRUITING
Cincinnati
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Oregon
VA Portland Health Care System, Portland, OR
RECRUITING
Portland
South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITING
Charleston
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
RECRUITING
Columbia
Tennessee
Memphis VA Medical Center, Memphis, TN
RECRUITING
Memphis
Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITING
Dallas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITING
Salt Lake City
Virginia
Hunter Holmes McGuire VA Medical Center, Richmond, VA
RECRUITING
Richmond
Salem VA Medical Center, Salem, VA
RECRUITING
Salem
Wisconsin
Clement J. Zablocki VA Medical Center, Milwaukee, WI
RECRUITING
Milwaukee
West Virginia
Huntington VA Medical Center, Huntington, WV
RECRUITING
Huntington
Contact Information
Primary
Gregory G Schwartz, PhD MD
Gregory.Schwartz@va.gov
(720) 723-6070
Backup
Kevin Gropp
kevin.gropp@va.gov
(720) 857-5659
Time Frame
Start Date: 2023-04-03
Estimated Completion Date: 2029-09-28
Participants
Target number of participants: 7410
Treatments
Experimental: Metformin
Participants receive initial treatment with metformin XR 500 mg 1 tablet daily, with stepwise titration to a maximum dose of 2000 mg (4 tablets) daily.
Placebo_comparator: Placebo
Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov