"MetCool ACS"- Metformin "Cooling" Effect on metformin-naive Patients Treated with PCI because of Acute Coronary Syndrome

2024-516589-13-00 Protocol MC-ACS01-2020 Therapeutic confirmatory (Phase III) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 24 sites · Protocol MC-ACS01-2020

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Authorised, recruitment pending
Participants planned 1,000
Countries 1
Sites 24

Acute coronary syndrome

The primary objective of the study is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.

Key facts

Sponsor
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2024-11-18
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2024-516589-13-00
EudraCT number
2020-004962-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Prophylaxis, Safety

The primary objective of the study is to evaluate the effect of metformin in reducing the rate of unplanned coronary revascularization in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.

Secondary objectives 2

  1. To evaluate the effects of metformin on other major cardiovascular events in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.
  2. To assess the safety of metformin use in nondiabetic patients treated with percutaneous coronary angioplasty (PCI) for acute coronary syndrome.

Conditions and MedDRA coding

Acute coronary syndrome

VersionLevelCodeTermSystem organ class
20.0 HLGT 10011082 Coronary artery disorders 10007541
20.0 HLT 10011085 Ischaemic coronary artery disorders 10007541
20.0 SOC 10007541 Cardiac disorders 11
20.0 PT 10051592 Acute coronary syndrome 100000004849

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Age >18 years
  2. First episode of the ACS in accordance with ESC (European Society of Cardiology) treating with percutaneous coronary intervention with drug-eluting stent implantation
  3. Profession, place of residence (but close enough that it will not cause difficulty in monitoring during research)
  4. Uncomplicated course of the disease (ACS) as assessed by the treating physician
  5. Patient negative history of diabetes
  6. No hypoglycemic drugs before the admission or in the last 6 months
  7. HbA1c< 6,5% (assessment during hospitalization)
  8. Written consent to participate in the study

Exclusion criteria 11

  1. Significant valvular disease confirmed in ECHO
  2. History of previous CABG
  3. NYHA IV during hospitalization
  4. Chronic kidney disease with GFR< 60 ml/min/1,73 m2 modo MDRD
  5. ALT three times over UNL (upper normal limit) according to the laboratory criteria
  6. Serious co-morbidity and estimated survival time of less than 2.5 years- as assessed by the treating physician
  7. Known gastro-intestinal disease which could be potentially responsible for metformin intolerance (eg inflammatory bowel disease, GERD- gastro-esophageal reflux disease)- this criterion only for patients from "treatment group"
  8. Known potential difficulties in collaboration with patients (dementia, mental disorders, distance from patients residence if considered as potentially problematic, alcoholism)
  9. Hypersensivity to metformin
  10. Pregnancy and breast - breeding
  11. Patient participation in another study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The need to perform unplanned PCI or CABG after successful last stage of full revascularization because of ACS

Secondary endpoints 4

  1. Cardiac death after successful final stage of revascularization due to ACS in the 30-month follow-up period
  2. Death from any cause after successful final stage of revascularization due to ACS in the 30-month follow-up period
  3. Non-fatal myocardial infarction after successful final stage of revascularization due to ACS in the 30-month follow-up period
  4. Non-fatal stroke after successful final stage of revascularization due to ACS in the 30-month follow-up period

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Metformin

SUB08831MIG · Substance

Active substance
Metformin
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
2550 mg milligram(s)
Max total dose
3000 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Metformin

SUB08831MIG · Substance

Active substance
Metformin
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
2550 mg milligram(s)
Max total dose
3000 mg milligram(s)
Max treatment duration
24 Month(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

9 Total trials 5 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Address
Ulica Szaserow 128
City
Warsaw
Postcode
04-141
Country
Poland

Scientific contact point

Organisation
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Contact name
Piotr Kwiatkowski

Public contact point

Organisation
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Contact name
Piotr Kwiatkowski

Third parties 1

OrganisationCity, countryDuties
Soft Communication Danuta Moreń
ORL-000010799
 Warszawa, Poland On site monitoring, Code 10, Code 11, Code 12, Other, Data management, E-data capture, Code 8, Code 9

Locations

1 EU/EEA country · 24 investigational sites

By country

CountryMS statusPlanned subjectsSites
Poland Authorised, recruitment pending 1,000 24
Rest of world — 0 —

Investigational sites

Poland

24 sites · Authorised, recruitment pending
Centrum Kardiologii Scanmed w Ełku
Oddział Kardiologii, Baranki 25, 19-300, Ełk
Centrum Kardiologii Scanmed w Bielsku Podlaskim
Oddział Kardiologii, ul. Kleszczelowska 1, 17-100, Bielsk Podlaski
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Kardiologii i Chorób Wewnętrznych, Ulica Szaserow 128, 04-141, Warsaw
Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wlkp. Spółka z Ograniczoną Odpowiedzialnością
Oddział Kardiologii, Dekerta 1, 66-400, Gorzów Wlkp
Scanmed S.A.
Oddział Kardiologii, Ul. Strzelcow Bytomskich 11, 41-500, Chorzow
American Heart Of Poland S.A.
X Oddział Kardiologii Inwazyjnej, Elektrofizjologii i Elektrostymulacji, Ul. Edukacji 102, 43-100, Tychy
Szpital sw. Rafala Scanmed SA
Oddział Kardiologii, ul. Bochenka 12, 30-693, Krakow
Scanmed S.A.
Oddział Kardiologii, Ul. Adama Mickiewicza 12, 42-217, Czestochowa
American Heart Of Poland S.A.
III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii, Ul. Szpitalna 13, 41-300, Dabrowa Gornicza
Centrum Kardiologii Scanmed w Iławie
Oddział Kardiologii, Gen. Andersa 3, 14-202, Iława
Centrum Kardiologii Scanmed w Sosnowcu
Oddział Kardiologii, Szpitalna 1, 41-219, Sosnowiec
Centrum Kardiologii Scanmed w Szczecinku
Oddział Kardiologii, Kilińskiego 7, 78-400, Szczecinek
4Cardia Szpital Kardiologii Inwazyjnej z Oddziałem Chirurgii Naczyniowej
Oddział Kardiologii, Szpitalna 4c, 23-204, Kraśnik
Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim
Oddział Kardiologii, Jana Pawła II 35, 97-200, Tomaszów Mazowiecki
Scanmed S.A.
Oddział Kardiologii, Ul. Kosciuszki 52, 99-300, Kutno
Uniwersyteckie Centrum Kliniczne
I Klinika Kardiologii, Ul. Debinki 7, 80-211, Gdansk
NZOZ Pomorskie Centra Kardiologiczne
Oddział Kardiologii, ul. Wolności 3, 11-700, Mrągowo
Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Pulawach
Oddział Kardiologii, Ul. Jozefa Bema 1, 24-100, Pulawy
Scanmed S.A.
Oddział Kardiologii, Ul. Sklodowskiej-Curie 23, 46-200, Kluczbork
Wojskowy Instytut Medyczny - Szpital w Legionowie
Oddzial Kardiologii Interwencyjnej i Chorob Wewnetrznych, Zegrzynska 8, 05-119, Legionowo
American Heart Of Poland S.A.
Zgierskie Centrum Kardiologii Med-Pro, Ul. Parzeczewska 35, 95-100, Zgierz
American Heart Of Poland S.A.
Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej, Aleja Armii Krajowej 101, 43-316, Bielsko-Biala
Małopolskie Centrum Sercowo-Naczyniowe AhoP
Oddział Kardiologii, Topolowa 16, 32500, Chrzanów
Centrum Kardiologii Scanmed w Raciborzu
Oddział Kardiologii, Gamowska 3a, 47-400, Racibórz

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_ Protocol EU CT 2020-004962-21_redacted 3.1
Recruitment arrangements (for publication) K1_Recruitment arrangements_redacted 1
Subject information and informed consent form (for publication) L1_ SIS and ICF adulds_redacted 3.2
Summary of Product Characteristics (SmPC) (for publication) E2_ SmPC Glucophage 850mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Glucophage 500mg 1
Summary of Product Characteristics (SmPC) (for publication) G2_ SmPC Glucophage 500mg 1
Synopsis of the protocol (for publication) D1_Protocol synopsis MS 2024-516589-13-00 PL 3.1

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-09-17 Poland Acceptable
2024-11-12
 2024-11-18
2 NON SUBSTANTIAL MODIFICATION NSM-4 2025-02-14 Poland Acceptable
2024-11-12
 2025-02-14
3 SUBSTANTIAL MODIFICATION SM-1 2025-07-17 Poland Acceptable
2025-09-08
 2025-09-12
4 NON SUBSTANTIAL MODIFICATION NSM-5 2025-09-17 Poland Acceptable
2025-09-08
 2025-09-17

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