Evaluation of safety i efficacy de-escalation antiplatelet strategies in acute coronary syndrome.

Phase 1

• Conditions: Acute Coronary Syndrom (ACS); MedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2020-005130-15-PL
• Lead Sponsor: icolaus Copernicus University in Torun

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 4500

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 <40 years, or =1.5 mm in women regardless of age; or a new left bundle-branch block, and
2) the intention to perform primary percutaneous coronary intervention (PCI), and
3)detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.
For patients NSTEMI-ACS, at least two of the following three criteria will have to be met:
1)symptoms indicating myocardial ischemia;
2)ST-segment changes on electrocardiography indicating myocardial ischemia;
3)detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit;
in addition to at least one of the following:
- =60 years of age;
- previous myocardial infarction or coronary artery by-pass grafting;
- =50% stenosis in =2 coronary arteries;
- previous ischemic stroke or Transient Ischemic Attack (TIA);
- =50% carotid stenosis or cerebral revascularization;
- diabetes mellitus;
- peripheral artery disease;
- chronic kidney disease with glomerular filtration rate <60 mL/min.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2025
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2475

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified