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Acute Coronary SyndromePhase 3NCT05305898

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

A Phase 3 study testing Metformin in people with Acute Coronary Syndrome, run by Military Institute od Medicine National Research Institute at 14 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
14 sitesPoland
Study dates
8 Feb 2022to Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

Piotr Kwiatkowski contact

606619195

pkwiatkowski@wim.mil.pl

14 sites in 1 country

Poland14 sites, 14 recruiting

  • Centrum Kardiologii Scanmed w Bielsku Podlaskim

    Bielsk Podlaski, Podlaskie Voivodeship, 17-100

    Dariusz Bielecki, PhD

    Not yet recruiting

  • Chorzowskie Centrum Kardiologii

    Chorzów, Silesian Voivodeship, 41-500

    Agata Fenger, MD

    Not yet recruiting

  • Częstochowskie Centrum Kardiologii

    Częstochowa, Śląske, 42-200

    Lucjan Szela, MD

    Not yet recruiting

  • Centrum Kardiologii Scanmed w Ełku

    Ełk, Warmian-Masurian Voivodeship, 19-300

    Artur Zalewski, PhD

    Not yet recruiting

  • Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim

    Gorzów Wielkopolski, Lubusz Voivodeship, 66-400

    Roman Mycka, PhD

    Not yet recruiting

  • Centrum Kardiologii Scanmed w Iławie

    Iława, Warmian-Masurian Voivodeship, 14-202

    Rafał Tomaszewski, MD

    Not yet recruiting

  • Kluczborskie Centrum Kardiologii

    Kluczbork, Opole Voivodeship, 46-200

    Andrzej Wester, PhD

    Not yet recruiting

  • Oddział Kardiologii Szpitala św. Rafała

    Krakow, Lesser Poland Voivodeship, 30-693

    Jerzy Matysek, PhD

    Not yet recruiting

  • Centrum Kardiologii Scanmed w Kutnie

    Kutno, Łódź Voivodeship, 99-320

    Radosław Kręcki, PhD

    Not yet recruiting

  • Raciborskie Centrum Medyczne

    Racibórz, Silesian Voivodeship, 47-400

    Marek Szymiczek, MD

    Not yet recruiting

  • Sosnowieckie Centrum Kardiologii

    Sosnowiec, Silesian Voivodeship, 41-219

    Jacek Olender, PhD

    Not yet recruiting

  • Centrum Kardiologii Scanmed w Szczecinku

    Szczecinek, West Pomeranian Voivodeship, 78-400

    Wojciech Jabłoński, MD

    Not yet recruiting

  • Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim

    Tomaszów Mazowiecki, Łódź Voivodeship, 97-200

    Piotr Paliński, MD

    Not yet recruiting

  • Wojskowy Instytut Medyczny

    Warsaw, Masovian Voivodeship, 04-141

    Grzegorz Gierelak, Professor

    Recruiting

Other trials in Poland

About this study

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

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).

Being tested
Metformin
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05305898
Study groupRoleWhat they receive
Metformin groupExperimentalPatients 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.
Receives: Drug: Metformin
No metformin groupNo interventionPatients form "no metformin" group will be observed for 2 years and 6 months, which cover the same period like for patients from metformin group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: through study completion, an average of 5 years

Secondary outcomes (4)

  1. 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

    Measured: through study completion, an average of 5 years

  2. 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

    Measured: through study completion, an average of 5 years

  3. 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

    Measured: through study completion, an average of 5 years

  4. 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

    Measured: through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start8 Feb 2022
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305898
Sponsor's protocol ID
MC-ACS01-2020
Other IDs
2020-004962-21
Status last verified
Mar 2022
First submitted
17 Feb 2022
Last updated
31 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin in people with Acute Coronary Syndrome, run by Military Institute od Medicine National Research Institute at 14 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Piotr Kwiatkowski (606619195, pkwiatkowski@wim.mil.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period (time frame: through study completion, an average of 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05305898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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