A Randomized, Open-label, Pharmacodynamic and Pharmacokinetic Trial Assessing the Effect of Lowering Ticagrelor Maintenance Dose Early After Myocardial Infarction on Platelet Inhibition (ELECTRA Pilot Study).

CMUMK202H

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 patients who recently underwent acute myocardial infarction and were treated with percutaneous coronary intervention.

2017-08-11

2018-02-23

2018-02-23

Completed

Early phase I

52

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ACTUAL'}}

2023-04-21