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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-11

Study Completion Date

2018-02-23

Brief Summary

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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.

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Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard ticagrelor maintenance dose

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

Group Type ACTIVE_COMPARATOR

Ticagrelor 90 mg

Intervention Type DRUG

Ticagrelor 90 mg twice daily

Reduced ticagrelor maintenance dose

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.

Group Type EXPERIMENTAL

Ticagrelor 90 mg

Intervention Type DRUG

Ticagrelor 90 mg twice daily

Ticagrelor 60 mg

Intervention Type DRUG

Ticagrelor 60 mg daily

Interventions

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Ticagrelor 90 mg

Ticagrelor 90 mg twice daily

Intervention Type DRUG

Ticagrelor 60 mg

Ticagrelor 60 mg daily

Intervention Type DRUG

Other Intervention Names

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Brilique 90 mg Brilique 60 mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No