Clinical trial NCT05305898: "MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
Official title: MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
Collaborators: name: ABM Industries
First posted: 2022-03-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


Eligibility 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

Primary outcomes:
measure: Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Death from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up
timeFrame: through study completion, an average of 5 years
measure: All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period
timeFrame: through study completion, an average of 5 years
measure: Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up
timeFrame: through study completion, an average of 5 years
measure: Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Gorzów Wielkopolski
country: Poland
facility: Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim
state: Lubuskie
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny
state: Mazowieckie
city: Kraków
country: Poland
facility: Oddział Kardiologii Szpitala św. Rafała
state: Małopolskie
city: Kluczbork
country: Poland
facility: Kluczborskie Centrum Kardiologii
state: Opolskie
city: Bielsk Podlaski
country: Poland
facility: Centrum Kardiologii Scanmed w Bielsku Podlaskim
state: Podlaskie
city: Ełk
country: Poland
facility: Centrum Kardiologii Scanmed w Ełku
state: Warmińsko-Mazurskie
city: Iława
country: Poland
facility: Centrum Kardiologii Scanmed w Iławie
state: Warmińsko-Mazurskie
city: Szczecinek
country: Poland
facility: Centrum Kardiologii Scanmed w Szczecinku
state: Zachodniopomorskie
city: Kutno
country: Poland
facility: Centrum Kardiologii Scanmed w Kutnie
state: Łódzkie
city: Tomaszów Mazowiecki
country: Poland
facility: Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim
state: Łódzkie
city: Częstochowa
country: Poland
facility: Częstochowskie Centrum Kardiologii
state: Śląske
city: Chorzów
country: Poland
facility: Chorzowskie Centrum Kardiologii
state: Śląskie
city: Racibórz
country: Poland
facility: Raciborskie Centrum Medyczne
state: Śląskie
city: Sosnowiec
country: Poland
facility: Sosnowieckie Centrum Kardiologii
state: Śląskie
Study officials:
affiliation: Military Institute of Medicine
name: Grzegorz Gierelak
role: PRINCIPAL_INVESTIGATOR
References: