Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study

Collegium Medicum w Bydgoszczy

Status and phase: Completed; Phase 3

Conditions: Myocardial Infarction

Treatments: Drug: Ticagrelor 90 mg; Drug: Ticagrelor 60 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03251859

CMUMK202H

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Standard ticagrelor maintenance dose

Active Comparator group

Description:

Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.

Treatment:

Drug: Ticagrelor 90 mg

Reduced ticagrelor maintenance dose

Experimental group

Description:

Ticagrelor 90 mg twice daily for the first 30 days after myocardial infarction treated with percutaneous coronary intervention, then reduction of the maintenance dose to ticagrelor 60 mg twice daily for the next 15 days.

Treatment:

Drug: Ticagrelor 60 mg

Drug: Ticagrelor 90 mg