Status:
COMPLETED
Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study
Lead Sponsor:
Collegium Medicum w Bydgoszczy
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The ELECTRA pilot study is a randomized, open-label, pharmacokinetic and pharmacodynamic trial designed to evaluate the effect of ticagrelor maintenance dose reduction on platelet inhibition in stable...
Eligibility Criteria
Inclusion
- provision of informed consent prior to any study specific procedures
- diagnosis of acute ST-segment elevation myocardial infarction or acute non-ST-segment elevation myocardial infarction according to the Third Universal Definition of Myocardial Infarction
- index event treatment with percutaneous coronary intervention
- male or non-pregnant female, aged 18-80 years old
Exclusion
- contraindications for ticagrelor
- further coronary revascularization planned during the first 45 days after myocardial infarction
- indications for chronic treatment with oral anticoagulant or low-molecular-weight heparin
- active bleeding
- history of intracranial hemorrhage
- recent gastrointestinal bleeding (within 30 days)
- history of coagulation disorders
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- active neoplastic disease
- patient requiring dialysis
- chronic inflammatory disease
- current therapy with strong CYP3A inhibitors or strong CYP3A inducers
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2018
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03251859
Start Date
August 11 2017
End Date
February 23 2018
Last Update
April 21 2023
Active Locations (1)
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1
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-094