Myocardial InfarctionPhase 3NCT03251859
Effectiveness of Lower Maintenance Dose of Ticagrelor Early After Myocardial Infarction (ELECTRA) Pilot Study
A Phase 3 study testing Ticagrelor 90 mg and Ticagrelor 60 mg in people with Myocardial Infarction, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Ticagrelor 90 mg and Ticagrelor 60 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePoland
- Study dates
- 11 Aug 2017to 23 Feb 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Cardiology Department, Dr. A. Jurasz University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
About this 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).
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
- Being tested
- Ticagrelor 90 mg, Ticagrelor 60 mg
- Keywords
- platelet reactivity, ticagrelor, myocardial infarction, pharmacodynamics, antiplatelet therapy
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ticagrelor 90 mgDrug
Also called Brilique 90 mg
Ticagrelor 90 mg twice daily
Ticagrelor 60 mgDrug
Also called Brilique 60 mg
Ticagrelor 60 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Standard ticagrelor maintenance dose | Active comparator | Ticagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention. Receives: 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. Receives: Drug: Ticagrelor 90 mg; Drug: Ticagrelor 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Reactivity Assessed with the VASP assay
Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.
Measured: 45 days
Secondary outcomes (5)
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
Platelet inhibition evaluated with Multiple Electrode Aggregometry 45 days after myocardial infarction.
Measured: 45 days
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.
Measured: 45 days
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.
Measured: 45 days
Plasma concentration of Ticagrelor
Evaluation of ticagrelor plasma concentration 45 days after myocardial infarction.
Measured: 45 days
Plasma concentration of AR-C124910XX
Evaluation of ticagrelor active metabolite plasma concentration 45 days after myocardial infarction.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start11 Aug 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collegium Medicum w Bydgoszczy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacek Kubica, Collegium Medicum w Bydgoszczy
- Investigators
- Prof. Jacek Kubica, MD, PhD, Principal investigator, Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w ToruniuEliano Navarese, Md, PhD, Principal investigator, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251859
- Sponsor's protocol ID
- CMUMK202H
- Status last verified
- Apr 2023
- First submitted
- 14 Aug 2017
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30689800Kubica 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.
PubMed 29040445
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT03251859
- Acronym / sponsor ID
- CMUMK202H
- Conditions
- Myocardial Infarction
- Keywords
- platelet reactivity, ticagrelor, myocardial infarction, pharmacodynamics, antiplatelet therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 11 Aug 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ticagrelor maintenance dose | Active comparator | Drug: Ticagrelor 90 mgTicagrelor 90 mg twice daily for the first 45 days after myocardial infarction treated with percutaneous coronary intervention. |
| Reduced ticagrelor maintenance dose | Experimental | Drug: Ticagrelor 90 mg, Drug: Ticagrelor 60 mgTicagrelor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ticagrelor 90 mgAlso: Brilique 90 mgTicagrelor 90 mg twice daily | Drug | Reduced ticagrelor maintenance dose, Standard ticagrelor maintenance dose |
| Ticagrelor 60 mgAlso: Brilique 60 mgTicagrelor 60 mg daily | Drug | Reduced ticagrelor maintenance dose |
Primary outcome
Platelet Reactivity Assessed with the VASP assay
Time frame: 45 days
Platelet inhibition evaluated with the VASP assay 45 days after myocardial infarction.
5 secondary outcomes
Platelet Reactivity Assessed with Multiple Electrode Aggregometry
Time frame: 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 Multiple Electrode Aggregometry
Time frame: 45 days
Plasma concentration of Ticagrelor
Time frame: 45 days
Plasma concentration of AR-C124910XX
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 30689800Kubica 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.
- Derived from this study: PubMed 29040445Kubica 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.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Jacek Kubica, MD, PhD principal investigator
Collegium Medicum im. Ludwika Rydygiera w Bydgoszczy, Uniwersytet Mikołaja Kopernika w Toruniu
Eliano Navarese, Md, PhD principal investigator
Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ticagrelor 90 mg and Ticagrelor 60 mg in people with Myocardial Infarction, run by Collegium Medicum w Bydgoszczy at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Reactivity Assessed with the VASP assay (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251859, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.