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Completed

NCT Number: NCT03251859

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

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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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cardiology Department, Dr. A. Jurasz University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 90 MG

Drug

Ticagrelor 90 mg twice daily

Other names: Brilique 90 mg

Ticagrelor 60 mg

Drug

Ticagrelor 60 mg daily

Other names: Brilique 60 mg

Primary outcomes

  1. Platelet Reactivity Assessed with the VASP assay

    Time frame: 45 days

    Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.

Secondary outcomes

  1. Platelet Reactivity Assessed with Multiple Electrode Aggregometry

    Time frame: 45 days

    Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.

  2. Number of Patients With High Platelet Reactivity according to the VASP assay

    Time frame: 45 days

    Number of Patients With High Platelet Reactivity according to the VASP assay 45 days after myocardial infarction.

  3. Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry

    Time frame: 45 days

    Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry 45 days after myocardial infarction.

  4. Plasma concentration of Ticagrelor

    Time frame: 45 days

    Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.

  5. Plasma concentration of AR-C124910XX

    Time frame: 45 days

    Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.

Sponsors and collaborators

Lead sponsor

Collegium Medicum w Bydgoszczy

Other

Registry information

Official study title

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).

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 16, 2017
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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