Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome (ELECTRA-SIRIO)
STEMI, NSTEMI, Unstable Angina
About this trial
This is an interventional treatment trial for STEMI focused on measuring ticagrelor, aspirin, acute coronary syndrome
Eligibility Criteria
Inclusion Criteria:
- diagnosis of STEMI or NSTEMI or unstable angina
- 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 2) the intention to perform primary PCI 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 with NSTEMI or unstable angina, at least two of the following three criteria will have to be met:
- symptoms indicating myocardial ischaemia
- ST-segment changes on electrocardiography indicating myocardial ischaemia
- 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 MI or coronary artery by-pass grafting;
- ≥50% stenosis in ≥2 coronary arteries;
- previous ischaemic stroke or transient ischaemic attack;
- ≥50% carotid stenosis or cerebral revascularisation;
- diabetes mellitus;
- peripheral artery disease;
- chronic kidney disease with glomerular filtration rate <60 mL/min.
Exclusion Criteria:
- contraindications to ticagrelor or/and aspirin
- indications for 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
- pregnancy
Sites / Locations
- Antoni Jurasz University Hospital No. 1Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
Low-dose ticagrelor with aspirin (LDTA)
Low-dose ticagrelor with placebo (LDTP)
Standard-dose ticagrelor with aspirin (SDTA)
Patients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, and will receive the following antiplatelet therapy: ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS; ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until 12 months after ACS.
Patients with ACS in this arm will be subject to reduction of ticagrelor maintenance dose from 2x90mg to 2x60mg after the first month post-ACS, followed by discontinuation of aspirin after 3 months post-ACS, and will receive the following antiplatelet therapy: ticagrelor 2x90mg + aspirin 1x100mg during the first 30 days after ACS; ticagrelor 2x60mg + aspirin 1x100mg starting from day 31 until day 90 after ACS; ticagrelor 2x60mg + placebo starting from day 91 until 12 months after ACS.
Patients with ACS in this arm will receive standard dual antiplatelet therapy including ticagrelor 2x90mg + aspirin 1x100mg during the whole 12 months after ACS.