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

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).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03251859

Enrollment

Registered

2017-08-16

Start date

2017-08-11

Completion date

2018-02-23

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

platelet reactivity, ticagrelor, myocardial infarction, pharmacodynamics, antiplatelet therapy

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

Interventions

DRUGTicagrelor 90 mg

Ticagrelor 90 mg twice daily

DRUGTicagrelor 60 mg

Ticagrelor 60 mg daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Platelet Reactivity Assessed with the VASP assay	45 days	Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.

Secondary

Measure	Time frame	Description
Platelet Reactivity Assessed with Multiple Electrode Aggregometry	45 days	Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.
Number of Patients With High Platelet Reactivity according to the VASP assay	45 days	Number of Patients With High Platelet Reactivity according to the VASP assay 45 days after myocardial infarction.
Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry	45 days	Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry 45 days after myocardial infarction.
Plasma concentration of Ticagrelor	45 days	Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.
Plasma concentration of AR-C124910XX	45 days	Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026