Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
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|ClinicalTrials.gov Identifier: NCT02915198|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2016
Last Update Posted : June 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Prediabetic State Atherosclerosis Metformin||Drug: Metformin XR Drug: Placebo||Phase 4|
CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in patients with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA1c, fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m2; and do not fulfill any exclusion criteria. Patients who are eligible and agree to participate are randomly assigned to treatment with metformin XR (titrated to a maximum dose of 2000 mg daily based on safety and tolerability) or matching placebo. All patients receive counseling on therapeutic lifestyle recommendations.
CSP #2002 had a Pilot Phase trial from 2/2019 to 1/2021 and was approved for the full-scale trial, with projected full-scale launch in 10/2022.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||7410 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)|
|Estimated Study Start Date :||October 1, 2022|
|Estimated Primary Completion Date :||September 30, 2028|
|Estimated Study Completion Date :||September 30, 2028|
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.
Drug: Metformin XR
The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.
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.
For patients < 80 years of age at the time of a study visit, and with most recent eGFR 45 mL/min/1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo.
For patients 80 years of age or with most recent 30 eGFR < 45 mL/min/1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo
- Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization [ Time Frame: through study completion, an average of 4.5 years ]The primary outcome measure is the time to first occurrence of death, non-fatal myocardial infarction or stroke, hospitalization for unstable angina with objective evidence of acute myocardial ischemia, or coronary revascularization driven by acute or progressive symptoms.
- Time in days to Cardiovascular Outcomes [ Time Frame: through study completion, an average of 4.5 years ]
- Time to first occurrence of death, myocardial infarction, or stroke
- Time to first occurrence of a primary endpoint event, peripheral arterial disease event, or hospitalization for congestive heart failure
- Cumulative incidence of all components of the primary endpoint, including recurrent or multiple events in the same participant
- Cumulative incidence and time to first occurrence of each component of the primary outcome measure, peripheral arterial disease events, and hospitalization for congestive heart failure
- Time in days to Oncologic Outcome [ Time Frame: through study completion, an average of 4.5 years ]Time to new or recurrent diagnosis of a malignancy or death from a malignancy
- Time in days to Diabetes Outcome [ Time Frame: through study completion, an average of 4.5 years ]Time to new diagnosis of type 2 diabetes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915198
|Contact: Gregory G Schwartz, PhD MD||(720) 723-6070||Gregory.Schwartz@va.gov|
|Study Chair:||Gregory G. Schwartz, PhD MD||Rocky Mountain Regional VA Medical Center, Aurora, CO|