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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-08

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Metformin group

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.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

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.

No metformin group

Patients form "no metformin" group will be observed for 2 years and 6 months, which cover the same period like for patients from metformin group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grzegorz Gierelak

Role: PRINCIPAL_INVESTIGATOR

Military Institute of Medicine

Locations

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