Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004962-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ABM Industries | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Kwiatkowski | Contact | 606619195 | pkwiatkowski@wim.mil.pl |
| Name | Affiliation | Role |
|---|---|---|
| Grzegorz Gierelak | Military Institute of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oddział Kardiologii Szpitala św. Rafała | Not yet recruiting | Krakow | Lesser Poland Voivodeship | 30-693 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Number of all-cause deaths 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 | Number of non-fatal myocardial infarctions 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 | Number of non-fatal strokes after successful final stage of revascularization due to ACS within 30 | through study completion, an average of 5 years |
| Wielospecjalistyczny Szpital Wojewódzki w Gorzowie Wielkopolskim | Not yet recruiting | Gorzów Wielkopolski | Lubusz Voivodeship | 66-400 | Poland |
|
| Wojskowy Instytut Medyczny | Recruiting | Warsaw | Masovian Voivodeship | 04-141 | Poland |
|
| Kluczborskie Centrum Kardiologii | Not yet recruiting | Kluczbork | Opole Voivodeship | 46-200 | Poland |
|
| Centrum Kardiologii Scanmed w Bielsku Podlaskim | Not yet recruiting | Bielsk Podlaski | Podlaskie Voivodeship | 17-100 | Poland |
|
| Chorzowskie Centrum Kardiologii | Not yet recruiting | Chorzów | Silesian Voivodeship | 41-500 | Poland |
|
| Raciborskie Centrum Medyczne | Not yet recruiting | Racibórz | Silesian Voivodeship | 47-400 | Poland |
|
| Sosnowieckie Centrum Kardiologii | Not yet recruiting | Sosnowiec | Silesian Voivodeship | 41-219 | Poland |
|
| Centrum Kardiologii Scanmed w Ełku | Not yet recruiting | Ełk | Warmian-Masurian Voivodeship | 19-300 | Poland |
|
| Centrum Kardiologii Scanmed w Iławie | Not yet recruiting | Iława | Warmian-Masurian Voivodeship | 14-202 | Poland |
|
| Centrum Kardiologii Scanmed w Szczecinku | Not yet recruiting | Szczecinek | West Pomeranian Voivodeship | 78-400 | Poland |
|
| Centrum Kardiologii Scanmed w Kutnie | Not yet recruiting | Kutno | Łódź Voivodeship | 99-320 | Poland |
|
| Centrum Kardiologii Scanmed w Tomaszowie Mazowieckim | Not yet recruiting | Tomaszów Mazowiecki | Łódź Voivodeship | 97-200 | Poland |
|
| Częstochowskie Centrum Kardiologii | Not yet recruiting | Częstochowa | Śląske | 42-200 | Poland |
|
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Not provided
Not provided