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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 3
Locations
Poland
Study Type
Interventional
Intervention
Ticagrelor 90 mg
Ticagrelor 60 mg
Sponsored by
Collegium Medicum w Bydgoszczy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring platelet reactivity, ticagrelor, myocardial infarction, pharmacodynamics, antiplatelet therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cardiology Department, Dr. A. Jurasz University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard ticagrelor maintenance dose

Reduced ticagrelor maintenance dose

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 14, 2017
Last Updated
April 20, 2023
Sponsor
Collegium Medicum w Bydgoszczy
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1. Study Identification

Unique Protocol Identification Number
NCT03251859
Brief Title
Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study
Official 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).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
February 23, 2018 (Actual)
Study Completion Date
February 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
platelet reactivity, ticagrelor, myocardial infarction, pharmacodynamics, antiplatelet therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard ticagrelor maintenance dose
Arm Type
Active Comparator
Arm Description
Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention.
Arm Title
Reduced ticagrelor maintenance dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 90 mg
Other Intervention Name(s)
Brilique 90 mg
Intervention Description
Ticagrelor 90 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 60 mg
Other Intervention Name(s)
Brilique 60 mg
Intervention Description
Ticagrelor 60 mg daily
Primary Outcome Measure Information:
Title
Platelet Reactivity Assessed with the VASP assay
Description
Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.
Time Frame
45 days
Secondary Outcome Measure Information:
Title
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
Description
Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.
Time Frame
45 days
Title
Number of Patients With High Platelet Reactivity according to the VASP assay
Description
Number of Patients With High Platelet Reactivity according to the VASP assay 45 days after myocardial infarction.
Time Frame
45 days
Title
Number of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry
Description
Percentage of Patients With High Platelet Reactivity according to Multiple Electrode Aggregometry 45 days after myocardial infarction.
Time Frame
45 days
Title
Plasma concentration of Ticagrelor
Description
Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.
Time Frame
45 days
Title
Plasma concentration of AR-C124910XX
Description
Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Jacek Kubica, MD, PhD
Organizational Affiliation
Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eliano Navarese, Md, PhD
Organizational Affiliation
Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiology Department, Dr. A. Jurasz University Hospital
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-094
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30689800
Citation
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.
Results Reference
derived
PubMed Identifier
29040445
Citation
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.
Results Reference
derived

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

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