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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05305898
• Other study ID #: MC-ACS01-2020
• Secondary ID: 2020-004962-21
• Status: Recruiting
• Phase: Phase 3
• Start date: February 8, 2022
• Est. completion date: December 2025

Study information

• Verified date: March 2022
• Source: Military Institute of Medicine, Poland
• Contact: Piotr Kwiatkowski
• Phone: 606619195
• Email: pkwiatkowski[@]wim.mil.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Poland	Centrum Kardiologii Scanmed w Bielsku Podlaskim	Bielsk Podlaski	Podlaskie
Poland	Chorzowskie Centrum Kardiologii	Chorzów	Slaskie
Poland	Czestochowskie Centrum Kardiologii	Czestochowa	Slaske
Poland	Centrum Kardiologii Scanmed w Elku	Elk	Warminsko-Mazurskie
Poland	Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim	Gorzów Wielkopolski	Lubuskie
Poland	Centrum Kardiologii Scanmed w Ilawie	Ilawa	Warminsko-Mazurskie
Poland	Kluczborskie Centrum Kardiologii	Kluczbork	Opolskie
Poland	Oddzial Kardiologii Szpitala sw. Rafala	Kraków	Malopolskie
Poland	Centrum Kardiologii Scanmed w Kutnie	Kutno	Lódzkie
Poland	Raciborskie Centrum Medyczne	Racibórz	Slaskie
Poland	Sosnowieckie Centrum Kardiologii	Sosnowiec	Slaskie
Poland	Centrum Kardiologii Scanmed w Szczecinku	Szczecinek	Zachodniopomorskie
Poland	Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim	Tomaszów Mazowiecki	Lódzkie
Poland	Wojskowy Instytut Medyczny	Warszawa	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland	ABM Industries

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 5 years
Secondary	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	through study completion, an average of 5 years
Secondary	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	through study completion, an average of 5 years
Secondary	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	through study completion, an average of 5 years
Secondary	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	through study completion, an average of 5 years