Evaluating metformin's effects on heart patients without diabetes
MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
This study tests if metformin can help heart patients who don't have diabetes recover better and reduce the chances of needing more heart procedures after their initial treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Military Institute od Medicine National Research Institute Academic / other |
| Locations | 14 sites (Gorzów Wielkopolski, Lubuskie and 13 other locations) |
| Trial ID | NCT05305898 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of metformin on patients who have experienced acute coronary syndrome (ACS) and are undergoing percutaneous coronary intervention (PCI) with drug-eluting stents. It focuses on metformin-naive individuals, meaning they have not previously taken diabetes medications. The primary goal is to assess whether metformin can reduce the need for unplanned revascularization after the initial treatment for ACS. Participants will be monitored for their health outcomes following the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced ACS and are not diabetic.
Not a fit: Patients with significant valve disease, previous coronary artery bypass grafting, or chronic kidney disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic option to improve outcomes for heart patients without diabetes.
How similar studies have performed: While the specific approach of using metformin in non-diabetic ACS patients is novel, previous studies have shown metformin's potential benefits in other cardiovascular contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * ACS, according to the current definition of the European Society of Cardiology, treated with percutaneous coronary intervention with drug eluting stent implantation * Occupation and place of residence not causing difficulties in participating in control visits * Uncomplicated course of the disease (ACS) as assessed by the treating physician * Negative history of diabetes * Not taking any hypoglycaemic drugs prior to hospitalization immediately or within the last 6 months * HbA1c\< 6,5% (assessment during hospitalization) * Written consent to participate in the study Exclusion Criteria: * Significant valve disease confirmed by ECHO * Previous CABG * NYHA IV during hospitalization * Chronic kidney disease with GFR \<60 ml / min / 1.73 m2 according to MDRD * ALT three times above normal according to laboratory criteria * Serious co-morbidities and estimated survival less than 2.5 years, as assessed by the treating physician * Known gastrointestinal disease that may potentially be responsible for the intolerance to metformin (e.g. inflammatory bowel disease, gastro-oesophageal reflux disease) * Known potential difficulties in cooperation with patients (dementia, mental disorders, distance from the place of residence, if considered potentially problematic, alcoholism) * Hypersensitivity to metformin * Pregnancy and breastfeeding * Patient participation in another clinical trial
Where this trial is running
Gorzów Wielkopolski, Lubuskie and 13 other locations
- Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim — Gorzów Wielkopolski, Lubuskie, Poland (Not_yet_recruiting)
- Wojskowy Instytut Medyczny — Warszawa, Mazowieckie, Poland (Recruiting)
- Oddział Kardiologii Szpitala św. Rafała — Kraków, Małopolskie, Poland (Not_yet_recruiting)
- Kluczborskie Centrum Kardiologii — Kluczbork, Opolskie, Poland (Not_yet_recruiting)
- Centrum Kardiologii Scanmed w Bielsku Podlaskim — Bielsk Podlaski, Podlaskie, Poland (Not_yet_recruiting)
- Centrum Kardiologii Scanmed w Ełku — Ełk, Warmińsko-Mazurskie, Poland (Not_yet_recruiting)
- Centrum Kardiologii Scanmed w Iławie — Iława, Warmińsko-Mazurskie, Poland (Not_yet_recruiting)
- Centrum Kardiologii Scanmed w Szczecinku — Szczecinek, Zachodniopomorskie, Poland (Not_yet_recruiting)
- Centrum Kardiologii Scanmed w Kutnie — Kutno, Łódzkie, Poland (Not_yet_recruiting)
- Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim — Tomaszów Mazowiecki, Łódzkie, Poland (Not_yet_recruiting)
- Częstochowskie Centrum Kardiologii — Częstochowa, Śląske, Poland (Not_yet_recruiting)
- Chorzowskie Centrum Kardiologii — Chorzów, Śląskie, Poland (Not_yet_recruiting)
- Raciborskie Centrum Medyczne — Racibórz, Śląskie, Poland (Not_yet_recruiting)
- Sosnowieckie Centrum Kardiologii — Sosnowiec, Śląskie, Poland (Not_yet_recruiting)
Study contacts
- Principal investigator: Grzegorz Gierelak — Military Institute of Medicine
- Study coordinator: Piotr Kwiatkowski
- Email: pkwiatkowski@wim.mil.pl
- Phone: 606619195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.