"MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome

Phase 3

Recruiting

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Metformin

• Registration Number: NCT05305898
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-08
• Study First Submitted: 2022-02-17
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-23
• Last Update Submitted: 2022-03-23
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin group	Metformin	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.

Primary Outcome Measures

Name	Time	Method
Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period	through study completion, an average of 5 years	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

Secondary Outcome Measures

Name	Time	Method
Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up	through study completion, an average of 5 years	Number of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS within 30 months of follow-up
Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up	through study completion, an average of 5 years	Number of non-fatal strokes after successful final stage of revascularization due to ACS within 30
Death from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up	through study completion, an average of 5 years	Number of deaths from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up
All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period	through study completion, an average of 5 years	Number of all-cause deaths following successful final stage revascularization for ACS within a 30-month follow-up period

Trial Locations

Locations (14)

Wojskowy Instytut Medyczny; 🇵🇱 Warszawa, Mazowieckie, Poland

Oddział Kardiologii Szpitala św. Rafała; 🇵🇱 Kraków, Małopolskie, Poland

Centrum Kardiologii Scanmed w Bielsku Podlaskim; 🇵🇱 Bielsk Podlaski, Podlaskie, Poland

Kluczborskie Centrum Kardiologii; 🇵🇱 Kluczbork, Opolskie, Poland

Centrum Kardiologii Scanmed w Ełku; 🇵🇱 Ełk, Warmińsko-Mazurskie, Poland

Centrum Kardiologii Scanmed w Iławie; 🇵🇱 Iława, Warmińsko-Mazurskie, Poland

Częstochowskie Centrum Kardiologii; 🇵🇱 Częstochowa, Śląske, Poland

Chorzowskie Centrum Kardiologii; 🇵🇱 Chorzów, Śląskie, Poland

Raciborskie Centrum Medyczne; 🇵🇱 Racibórz, Śląskie, Poland

Sosnowieckie Centrum Kardiologii; 🇵🇱 Sosnowiec, Śląskie, Poland

Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim; 🇵🇱 Tomaszów Mazowiecki, Łódzkie, Poland

Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim; 🇵🇱 Gorzów Wielkopolski, Lubuskie, Poland

Centrum Kardiologii Scanmed w Szczecinku; 🇵🇱 Szczecinek, Zachodniopomorskie, Poland

Centrum Kardiologii Scanmed w Kutnie; 🇵🇱 Kutno, Łódzkie, Poland