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

April 20, 2023 updated by: Jacek Kubica, Collegium Medicum w Bydgoszczy

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-094
        • Cardiology Department, Dr. A. Jurasz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard ticagrelor maintenance dose
Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.
Drug: Ticagrelor 90 mg
Ticagrelor 90 mg twice daily
Other Names:
  • Brilique 90 mg
Experimental: 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.
Drug: Ticagrelor 90 mg
Ticagrelor 90 mg twice daily
Other Names:
  • Brilique 90 mg
Drug: Ticagrelor 60 mg
Ticagrelor 60 mg daily
Other Names:
  • Brilique 60 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
Time Frame: 45 days
Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.
45 days
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.
45 days
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.
45 days
Plasma concentration of Ticagrelor
Time Frame: 45 days
Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.
45 days
Plasma concentration of AR-C124910XX
Time Frame: 45 days
Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collegium Medicum w Bydgoszczy

Investigators

  • Principal Investigator: Prof. Jacek Kubica, MD, PhD, Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu
  • Principal Investigator: Eliano Navarese, Md, PhD, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2017

Primary Completion (Actual)

February 23, 2018

Study Completion (Actual)

February 23, 2018

Study Registration Dates

First Submitted

August 14, 2017

First Submitted That Met QC Criteria

August 14, 2017

First Posted (Actual)

August 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUMK202H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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