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Evaluation of safety i efficacy de-escalation antiplatelet strategies in acute coronary syndrome.
EU CTIS ID: 2024-518090-34-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Subject is aged 18 and older.
- Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the 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. study as planned
You likely can't join if
- Contraindication to ticagrelor or/and ASA.
- Need for use of any oral anticoagulation therapy.
- Second or third grade atrio-ventricular block.
- Previous stent thrombosis on treatment with ticagrelor.
- End stage kidney disease with glomerular filtration rate <15 mL/min or on haemodialysis;
- Administration of prasugrel during the index event;
See the full eligibility criteria
Who can join
- 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.
- Subject is aged 18 and older.
- Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the 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. study as planned
What rules you out
- Contraindication to ticagrelor or/and ASA.
- Need for use of any oral anticoagulation therapy.
- Second or third grade atrio-ventricular block.
- Previous stent thrombosis on treatment with ticagrelor.
- End stage kidney disease with glomerular filtration rate <15 mL/min or on haemodialysis;
- Administration of prasugrel during the index event;
- Unreliability or lack of cooperation.
- Pregnancy.
- 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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.