Acute Coronary Syndrom (ACS) MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Aspirin Cardio 100mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Nicolaus Copernicus University in Torun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has signed Informed Consent Form and is able to understand the purpose and procedures required for the study and is willing to participate in the study. 2. Subject is aged 18 and older. 3. Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned and is diagnosed with ACS, including ST-elevation myocardial infarction (STEMI), non ST elevation myocardial infarction (NSTEMI) or unstable angina (UA). The diagnosis of STEMI and NSTEMI will be made according to the Fourth Universal Definition of Myocardial Infarction, and UA will be diagnosed according to the 2020 European Society of Cardiology (ESC) Guidelines for the management of ACS in patients presenting without persistent ST-segment elevation (NSTE ACS). For patients with STEMI the following three inclusion criteria will have to be met: 1) new ST-elevation at the J-point in two contiguous leads with the cut-point =1 mm in all leads other than leads V2–V3, where the following cut-points apply: =2mm in men =40 years; =2.5 mm in men =65 years) yes F.1.3.1 Number of subjects for this age range 2475
Exclusion criteria
Exclusion criteria: 1. Contraindication to ticagrelor or/and ASA. 2. Need for use of any oral anticoagulation therapy. 3. Second or third grade atrio-ventricular block. 4. Previous stent thrombosis on treatment with ticagrelor. 5. End stage kidney disease with glomerular filtration rate <15 mL/min or on haemodialysis; 6. Administration of prasugrel during the index event; 7. Unreliability or lack of cooperation. 8. Pregnancy. 9. As per the Investigator (or his designee) judgment, subject cannot participate in the study for any reason (e.g., medical, psychiatric and/or social reason).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess and compare clinical safety of two ticagrelor-based antiplatelet de-escalation strategies with standard dual antiplatelet therapy (DAPT). ;Secondary Objective: The secondary objective of the study is compare clinical efficacy of two ticagrelor-based antiplatelet de-escalation strategies with standard DAPT. ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Within 12 months of observation, in a time-to-event analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary endpoint is the composite of the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke in a time-to-event analysis. Secondary bleeding end points include: 1) BARC type 3 or 5 bleeding; 2) Thrombolysis in Myocardial Infarction (TIMI) major or minor bleeding; 3) Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate, severe, or life-threatening bleeding; 4) International Society of Thrombosis and Haemostasis (ISTH) major bleeding. Other secondary endpoints include: 1) death from any cause; 2) death from Cardiovascular causes (CV); 3) myocardial infarction, 4) ischemic stroke; 5) definite or probable stent thrombosis; 6) adherence to study treatment; 7) dyspnea. ;Timepoint(s) of evaluation of this end point: Is the composite of the first occurrence of death from any cause, nonfatal myocardial infarction, or nonfatal stroke in a time-to-event analysis. | — |
Countries
Poland
Contacts
Public ContactStudy coordinator
Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University
Outcome results
None listed