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 strategies in patients with acute coronary syndrome (ACS). During the hospitalization due to ACS, participants will be randomized in a 1:1:1 ratio into one of three arms: low-dose ticagrelor with aspirin (LDTA), low-dose ticagrelor with placebo (LDTP), and standard-dose ticagrelor with aspirin (SDTA), the latter being the control arm. Up to day 30, all enrolled patients will receive standard-dose ticagrelor (2x90mg) + aspirin (1x100mg). Starting from day 31 LDTA and LDTP patients will receive low-dose ticagrelor (2x60mg) + aspirin (1x100mg), SDTA - continuation of previous treatment. Starting from day 91 LDTP patients will receive low-dose ticagrelor (2x60mg) + placebo, SDTA and LDTA - continuation of previous treatment. The aim of the study is to evaluate the influence of ticagrelor maintenance dose reduction from 2x90mg to 2x60mg with or without continuation of aspirin versus dual antiplatelet therapy with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4,500
Up to day 30 after ACS, all enrolled patients will receive standard-dose ticagrelor 2x90mg as a part of dual antiplatelet therapy. Participants in SDTA arm will continue treatment with ticagrelor 2x90mg until 12 months post-ACS, while patients in LDTA and LDTP will be switched to low-dose ticagrelor 2x60 mg starting on day 31.
Starting from day 31, LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg until 12 months post-ACS.
Up to day 90 after ACS, all enrolled patients will receive aspirin 1x100mg as a part of dual antiplatelet therapy. Starting from day 91, LDTP patients will discontinue aspirin and proceed with low-dose ticagrelor monotherapy until 12 months post-ACS, while patients in LDTA and SDTA will continue aspirin 1x100 mg until 12 months post-ACS.
Antoni Jurasz University Hospital No. 1
Bydgoszcz, Poland
RECRUITINGBARC type 2, 3 or 5 bleeding
The primary safety composite end point of this study is the first occurrence of type 2, 3 or 5 bleeding according to the BARC criteria, occurring during the first 12 months after ACS.
Time frame: 12 months after ACS
Death from any cause, nonfatal MI or nonfatal stroke.
The primary efficacy end point is the composite of death from any cause, first nonfatal MI, or first nonfatal stroke.
Time frame: 12 months after ACS
Death from any cause, nonfatal MI, nonfatal stroke, BARC type 2, 3, or 5 bleeding.
The key secondary endpoint, net clinical effect, was defined as composite of death from any cause, nonfatal MI, or nonfatal stroke, and the first occurrence of BARC type 2, 3, or 5 bleeding.
Time frame: 12 months after ACS
BARC type 3 or 5 bleeding
Composite of the first occurrence of type 3 or 5 bleeding according to the BARC criteria.
Time frame: 12 months after ACS
TIMI major or minor bleeding
Composite of the first occurrence of major or minor bleeding according to the TIMI criteria.
Time frame: 12 months after ACS
GUSTO moderate, severe, or life-threatening bleeding
Composite of the first occurrence of moderate, severe, or life-threatening bleeding according to the GUSTO criteria.
Time frame: 12 months after ACS
ISTH major bleeding
The first occurrence of major bleeding according to the ISTH criteria.
Time frame: 12 months after ACS
Death from any cause
Death from any cause.
Time frame: 12 months after ACS
Death from cardiovascular causes
Death from cardiovascular causes.
Time frame: 12 months after ACS
Myocardial infarction
Occurrence of myocardial infarction.
Time frame: 12 months after ACS
Ischemic stroke
Occurrence of ischemic stroke.
Time frame: 12 months after ACS
Definite or probable stent thrombosis
Occurrence of definite or probable stent thrombosis
Time frame: 12 months after ACS
Dyspnea
Occurrence of dyspnea
Time frame: 12 months after ACS
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