Status:
UNKNOWN
Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome
Lead Sponsor:
Collegium Medicum w Bydgoszczy
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
STEMI
NSTEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The ELECTRA-SIRIO 2 study is a randomized, multicenter, double-blind, investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet str...
Eligibility Criteria
Inclusion
- 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:
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- ≥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
- 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
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
4500 Patients enrolled
Trial Details
Trial ID
NCT04718025
Start Date
February 7 2022
End Date
June 30 2024
Last Update
April 21 2023
Active Locations (1)
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1
Antoni Jurasz University Hospital No. 1
Bydgoszcz, Poland