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

NCT03251859 | Completed Phase 3

• 1 other identifier: CMUMK202H
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Platelet Reactivity Assessed with the VASP assay

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

  45 days

Secondary Outcomes (5)

• Platelet Reactivity Assessed with Multiple Electrode Aggregometry

  45 days

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

  45 days

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

  45 days

• Plasma concentration of Ticagrelor

  45 days

• Plasma concentration of AR-C124910XX

  45 days

Study Arms (2)

Standard ticagrelor maintenance dose

ACTIVE COMPARATOR

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

Drug: Ticagrelor 90 mg

Reduced ticagrelor maintenance dose

EXPERIMENTAL

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; Drug: Ticagrelor 60 mg

Interventions

Ticagrelor 90 mg DRUG

Ticagrelor 90 mg twice daily

Also known as: Brilique 90 mg

Reduced ticagrelor maintenance dose; Standard ticagrelor maintenance dose

Ticagrelor 60 mg DRUG

Ticagrelor 60 mg daily

Also known as: Brilique 60 mg

Reduced ticagrelor maintenance dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (1)

Cardiology Department, Dr. A. Jurasz University Hospital

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

Location

Related Publications (2)

• Kubica J, Adamski P, Buszko K, Baranska M, Sikora J, Marszall MP, Sobczak P, Sikora A, Kuliczkowski W, Fabiszak T, Kubica A, Jilma B, Alexopoulos D, Navarese EP. Platelet inhibition with standard vs. lower maintenance dose of ticagrelor early after myocardial infarction (ELECTRA): a randomized, open-label, active-controlled pharmacodynamic and pharmacokinetic study. Eur Heart J Cardiovasc Pharmacother. 2019 Jul 1;5(3):139-148. doi: 10.1093/ehjcvp/pvz004.

  PMID: 30689800 DERIVED

• Kubica J, Adamski P, Buszko K, Kubica A, Kuliczkowski W, Fabiszak T, Jilma B, Alexopoulos D, Paciorek P, Navarese EP. Rationale and Design of the Effectiveness of LowEr maintenanCe dose of TicagRelor early After myocardial infarction (ELECTRA) pilot study. Eur Heart J Cardiovasc Pharmacother. 2018 Jul 1;4(3):152-157. doi: 10.1093/ehjcvp/pvx032.

  PMID: 29040445 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Jacek Kubica, MD, PhD

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: August 11, 2017
• Primary Completion: February 23, 2018
• Study Completion: February 23, 2018
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

PL (1)