A Phase 3 interventional study of Metformin in Acute Coronary Syndrome, sponsored by Military Institute od Medicine National Research Institute. Recruiting at 14 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by Military Institute od Medicine National Research Institute · Phase 3, Interventional, and Other
The aim of the study is the evaluation of the effect of metformin among the patients without diabetes, on the incidence of reintervention, unplanned revascularization, after full percutaneous coronary revascularization as a result of the first episode of the acute coronary syndrome (ACS).
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Military Institute od Medicine National Research Institute is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients from "metformin group" will receive metformin 3 x 850 mg (after titration period) for 2 years (3 x 500 mg for first 6 weeks) with 6 months follow-up after treatment cessation.
Drug: Metformin
Patients form "no metformin" group will be observed for 2 years and 6 months, which cover the same period like for patients from metformin group.
Patients from "metformin group" will receive metformin 3 x 850 mg (after titration period) for 2 years (3 x 500 mg for first 6 weeks) with 6 months follow-up after treatment cessation.
Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
Number of patients who needs an unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
Time frame: through study completion, an average of 5 years
Death from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up
Number of deaths from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up
Time frame: through study completion, an average of 5 years
All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period
Number of all-cause deaths following successful final stage revascularization for ACS within a 30-month follow-up period
Time frame: through study completion, an average of 5 years
Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up
Number of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS within 30 months of follow-up
Time frame: through study completion, an average of 5 years
Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up
Number of non-fatal strokes after successful final stage of revascularization due to ACS within 30
Time frame: through study completion, an average of 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2022 (actual). Primary completion is estimated for Dec 2025, 46 months after the start.
Of 39 phase 3 interventional studies under Acute Coronary Syndrome, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 52. This study's planned 46 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Metformin
Military Institute od Medicine National Research Institute