NCT05305898

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2022

Typical duration for phase_3

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

February 17, 2022

Last Update Submit

March 23, 2022

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Metformin group

EXPERIMENTAL

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.

Drug: Metformin

No metformin group

NO INTERVENTION

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.

Interventions

MetforminDRUG

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.

Metformin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Oddział Kardiologii Szpitala św. Rafała

Krakow, Lesser Poland Voivodeship, 30-693, Poland

NOT YET RECRUITING

Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim

Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland

NOT YET RECRUITING

Wojskowy Instytut Medyczny

Warsaw, Masovian Voivodeship, 04-141, Poland

RECRUITING

Kluczborskie Centrum Kardiologii

Kluczbork, Opole Voivodeship, 46-200, Poland

NOT YET RECRUITING

Centrum Kardiologii Scanmed w Bielsku Podlaskim

Bielsk Podlaski, Podlaskie Voivodeship, 17-100, Poland

NOT YET RECRUITING

Chorzowskie Centrum Kardiologii

Chorzów, Silesian Voivodeship, 41-500, Poland

NOT YET RECRUITING

Raciborskie Centrum Medyczne

Racibórz, Silesian Voivodeship, 47-400, Poland

NOT YET RECRUITING

Sosnowieckie Centrum Kardiologii

Sosnowiec, Silesian Voivodeship, 41-219, Poland

NOT YET RECRUITING

Centrum Kardiologii Scanmed w Ełku

Ełk, Warmian-Masurian Voivodeship, 19-300, Poland

NOT YET RECRUITING

Centrum Kardiologii Scanmed w Iławie

Iława, Warmian-Masurian Voivodeship, 14-202, Poland

NOT YET RECRUITING

Centrum Kardiologii Scanmed w Szczecinku

Szczecinek, West Pomeranian Voivodeship, 78-400, Poland

NOT YET RECRUITING

Centrum Kardiologii Scanmed w Kutnie

Kutno, Łódź Voivodeship, 99-320, Poland

NOT YET RECRUITING

Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim

Tomaszów Mazowiecki, Łódź Voivodeship, 97-200, Poland

NOT YET RECRUITING

Częstochowskie Centrum Kardiologii

Częstochowa, Śląske, 42-200, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Grzegorz Gierelak

    Military Institute of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Kwiatkowski

CONTACT

606619195pkwiatkowski@wim.mil.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2022

First Posted

March 31, 2022

Study Start

February 8, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

PL(14)