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

Myocardial Infarction Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251859
• Other study ID #: CMUMK202H
• Status: Completed
• Phase: Phase 3
• Start date: August 11, 2017
• Est. completion date: February 23, 2018

Study information

• Verified date: April 2023
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 23, 2018
• Est. primary completion date: February 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Ticagrelor 90 mg
Ticagrelor 90 mg twice daily
• Ticagrelor 60 mg
Ticagrelor 60 mg daily

Locations

Country	Name	City	State
Poland	Cardiology Department, Dr. A. Jurasz University Hospital	Bydgoszcz	Kujawsko-pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Reactivity Assessed with the VASP assay	Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.	45 days
Secondary	Platelet Reactivity Assessed with Multiple Electrode Aggregometry	Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.	45 days
Secondary	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.	45 days
Secondary	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.	45 days
Secondary	Plasma concentration of Ticagrelor	Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.	45 days
Secondary	Plasma concentration of AR-C124910XX	Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.	45 days