BridgeMD
"MetCool ACS"- Metformin "Cooling" Effect on metformin-naive Patients Treated with PCI because of Acute Coronary Syndrome
EU CTIS ID: 2024-516589-13-00
What this study is testing
The primary objective of the study is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >18 years
- First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation
- Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research)
- Uncomplicated course of the disease (ACS) as assessed by the treating physician
- Patient negative history of diabetes
- No hypoglycemic drugs before the admission or in the last 6 months
You likely can't join if
- Significant valvular disease confirmed in ECHO
- Pregnancy and breast - breeding
- Patient participation in another study
- History of previous CABG
- NYHA IV during hospitalization
- Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD
See the full eligibility criteria
- Age >18 years
- First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation
- Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research)
- Uncomplicated course of the disease (ACS) as assessed by the treating physician
- Patient negative history of diabetes
- No hypoglycemic drugs before the admission or in the last 6 months
- HbA1c< 6,5% (assessment during hospitalization)
- Written consent to participate in the study
- Significant valvular disease confirmed in ECHO
- Pregnancy and breast - breeding
- Patient participation in another study
- History of previous CABG
- NYHA IV during hospitalization
- Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD
- ALT three times over UNL (upper normal limit) according to the laboratory criteria
- Serious co-morbidity and estimated survival time of less than 2.5 years- as assessed by the treating physician
- Known gastro-intestinal disease which could be potentially responsible for metformin intolerance (eg inflammatory bowel disease, GERD- gastro-esophageal reflux disease)- this criterion only for patients from "treatment group"
- Known potential difficulties in collaboration with patients (dementia, mental disorders, distance from patients residence if considered as potentially problematic, alcoholism)
- Hypersensivity to metformin
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.