Acute Coronary Syndrom (ACS)
Conditions
Brief summary
The primary end point os this project is the first occurrence of type 2, 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria, within 12 months of observation, in a time-to-event analysis. BARC type 2 bleeding is any clinically overt sign of haemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional., BARC type 3 bleeding is: a) overt bleeding with haemoglobin drop of 3 to <5 g/dL (provided it is related to bleed); transfusion with overt bleeding;, b) overt bleeding with hemoglobin drop ≥5 g/dL (provided it is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents;c) intracranial haemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision., BARC type 5 bleeding is fatal bleeding.
Detailed description
BARC type 3 or 5 bleeding, Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate, severe, or life-threatening bleeding;, International Society of Thrombosis and Haemostasis (ISTH) major bleeding, death from any cause, death from Cardiovascular causes (CV);, myocardial infarction, ischemic stroke, definite or probable stent thrombosis, adherence to study treatment, dyspnea
Interventions
Sponsors
Eligibility
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| BARC type 3 or 5 bleeding, Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate, severe, or life-threatening bleeding;, International Society of Thrombosis and Haemostasis (ISTH) major bleeding, death from any cause, death from Cardiovascular causes (CV);, myocardial infarction, ischemic stroke, definite or probable stent thrombosis, adherence to study treatment, dyspnea | — |
Primary
| Measure | Time frame |
|---|---|
| The primary end point os this project is the first occurrence of type 2, 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) criteria, within 12 months of observation, in a time-to-event analysis. BARC type 2 bleeding is any clinically overt sign of haemorrhage that is actionable and requires diagnostic studies, hospitalization, or treatment by a health care professional., BARC type 3 bleeding is: a) overt bleeding with haemoglobin drop of 3 to <5 g/dL (provided it is related to bleed); transfusion with overt bleeding;, b) overt bleeding with hemoglobin drop ≥5 g/dL (provided it is related to bleed); cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents;c) intracranial haemorrhage confirmed by autopsy, imaging, or lumbar puncture; intraocular bleed compromising vision., BARC type 5 bleeding is fatal bleeding. | — |
Countries
Poland