Back to results"MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
Primary Purpose
Acute Coronary Syndrome
Status
Recruiting
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional other trial for Acute Coronary Syndrome
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
Sites / Locations
- Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim
- Wojskowy Instytut MedycznyRecruiting
- Oddział Kardiologii Szpitala św. Rafała
- Kluczborskie Centrum Kardiologii
- Centrum Kardiologii Scanmed w Bielsku Podlaskim
- Centrum Kardiologii Scanmed w Ełku
- Centrum Kardiologii Scanmed w Iławie
- Centrum Kardiologii Scanmed w Szczecinku
- Centrum Kardiologii Scanmed w Kutnie
- Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim
- Częstochowskie Centrum Kardiologii
- Chorzowskie Centrum Kardiologii
- Raciborskie Centrum Medyczne
- Sosnowieckie Centrum Kardiologii
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Metformin group
No metformin group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT05305898
First Posted
February 17, 2022
Last Updated
March 23, 2022
Sponsor
Military Institute od Medicine National Research Institute
Collaborators
ABM Industries
1. Study Identification
Unique Protocol Identification Number
NCT05305898
Brief Title
"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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Military Institute od Medicine National Research Institute
Collaborators
ABM Industries
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
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.
Arm Title
No metformin group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Need for unscheduled PCI or CABG after successful final stage of revascularization due to ACS within a 30-month follow-up period
Description
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
Time Frame
through study completion, an average of 5 years
Secondary Outcome Measure Information:
Title
Death from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up
Description
Number of deaths from cardiac causes after successful final stage of revascularization due to ACS within 30 months of follow-up
Time Frame
through study completion, an average of 5 years
Title
All-cause death following successful final stage revascularization for ACS within a 30-month follow-up period
Description
Number of all-cause deaths following successful final stage revascularization for ACS within a 30-month follow-up period
Time Frame
through study completion, an average of 5 years
Title
Non-fatal myocardial infarction after successful final stage of revascularization due to ACS within 30 months of follow-up
Description
Number of non-fatal myocardial infarctions after successful final stage of revascularization due to ACS within 30 months of follow-up
Time Frame
through study completion, an average of 5 years
Title
Non-fatal stroke after successful final stage of revascularization due to ACS within 30 months of follow-up
Description
Number of non-fatal strokes after successful final stage of revascularization due to ACS within 30
Time Frame
through study completion, an average of 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Kwiatkowski
Phone
606619195
Email
pkwiatkowski@wim.mil.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grzegorz Gierelak
Organizational Affiliation
Military Institute of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim
City
Gorzów Wielkopolski
State/Province
Lubuskie
ZIP/Postal Code
66-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roman Mycka, PhD
Facility Name
Wojskowy Instytut Medyczny
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
04-141
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grzegorz Gierelak, Professor
Facility Name
Oddział Kardiologii Szpitala św. Rafała
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30-693
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerzy Matysek, PhD
Facility Name
Kluczborskie Centrum Kardiologii
City
Kluczbork
State/Province
Opolskie
ZIP/Postal Code
46-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrzej Wester, PhD
Facility Name
Centrum Kardiologii Scanmed w Bielsku Podlaskim
City
Bielsk Podlaski
State/Province
Podlaskie
ZIP/Postal Code
17-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dariusz Bielecki, PhD
Facility Name
Centrum Kardiologii Scanmed w Ełku
City
Ełk
State/Province
Warmińsko-Mazurskie
ZIP/Postal Code
19-300
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Zalewski, PhD
Facility Name
Centrum Kardiologii Scanmed w Iławie
City
Iława
State/Province
Warmińsko-Mazurskie
ZIP/Postal Code
14-202
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafał Tomaszewski, MD
Facility Name
Centrum Kardiologii Scanmed w Szczecinku
City
Szczecinek
State/Province
Zachodniopomorskie
ZIP/Postal Code
78-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wojciech Jabłoński, MD
Facility Name
Centrum Kardiologii Scanmed w Kutnie
City
Kutno
State/Province
Łódzkie
ZIP/Postal Code
99-320
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radosław Kręcki, PhD
Facility Name
Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim
City
Tomaszów Mazowiecki
State/Province
Łódzkie
ZIP/Postal Code
97-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piotr Paliński, MD
Facility Name
Częstochowskie Centrum Kardiologii
City
Częstochowa
State/Province
Śląske
ZIP/Postal Code
42-200
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucjan Szela, MD
Facility Name
Chorzowskie Centrum Kardiologii
City
Chorzów
State/Province
Śląskie
ZIP/Postal Code
41-500
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agata Fenger, MD
Facility Name
Raciborskie Centrum Medyczne
City
Racibórz
State/Province
Śląskie
ZIP/Postal Code
47-400
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Szymiczek, MD
Facility Name
Sosnowieckie Centrum Kardiologii
City
Sosnowiec
State/Province
Śląskie
ZIP/Postal Code
41-219
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacek Olender, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
"MetCool ACS"- Metformin "Cooling" Effect on Metformin-naive Patients Treated With PCI Because of Acute Coronary Syndrome
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