Acute Myocardial InfarctionDRAGONNCT03454841
Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
An observational study of Acute Myocardial Infarction, run by Collegium Medicum w Bydgoszczy at 2 sites in Poland.
Trial summary
The aim of this study is to compare circadian variability of antiplatelet effect of prasugrel and ticagrelor maintenance doses during the initial days after acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Prasugrel and Ticagrelor
- How many people
- 73 participants
- Where
- 2 sitesPoland
- Study dates
- 26 Feb 2018to 28 Feb 2019
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute myocardial infarction treated invasively.
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
- male or non-pregnant female, aged 18-75 years old
- provision of informed consent for angiography and percutaneous coronary intervention
Who cannot join
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor or prasugrel
- contraindications for ticagrelor or prasugrel
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
- history of ischemic stroke or transient ischemic attack
Show all 14Show fewer
- history of intracranial hemorrhage
- recent gastrointestinal bleeding (within 30 days)
- history of moderate or severe hepatic impairment
- history of major surgery or severe trauma (within 3 months)
- patient required dialysis
- manifest infection or inflammatory state
- concomitant therapy with strong CYP3A inhibitors (ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir) or strong CYP3A inducers (rifampicin, phenytoin, carbamazepine, dexamethasone, phenobarbital) within 14 days and during study treatment
- body weight below 60 kg
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094
Department of Cardiology, Wrocław Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556
About this study
Official title: Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
The aim of this study is to compare circadian variability of antiplatelet effect of prasugrel and ticagrelor maintenance doses during the initial days after acute myocardial infarction.
Read the detailed description
Prasugrel and ticagrelor are two oral P2Y12 receptor antagonists recommended as a part of dual antiplatelet therapy with aspirin in patients with acute myocardial infarction. Both drugs exert comparable antiplatelet effect following a loading dose. However, pharmacodynamic differences exist between these P2Y12 receptor inhibitors. Prasugrel is a prodrug that requires hepatic activation and permanently binds to platelet P2Y12 receptors, whereas ticagrelor is an active drug and blocks P2Y12 receptors reversibly. Another important difference is that prasugrel maintenance dose is administered once daily, while ticagrelor requires next dosage every 12 hours. These fundamental distinctions may affect the degree of platelet inhibition on maintenance doses during the first days after acute myocardial infarction.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Prasugrel, Ticagrelor
- Keywords
- prasugrel, ticagrelor, VASP, platelet reactivity, STEMI, NSTEMI
- Medical subject headings
- ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrasugrelDrug
Also called Efient
Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily
TicagrelorDrug
Also called Brilique
Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Prasugrel | Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin. Receives: Drug: Prasugrel | |
| Ticagrelor | Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin. Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian variability of platelet inhibition assessed with VASP
Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00
Measured: Day 4 after acute myocardial infarction
Circadian variability of platelet inhibition assessed with Multiplate
Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00
Measured: Day 4 after acute myocardial infarction
Secondary outcomes (8)
High platelet reactivity at 8:00 assessed with VASP
Number of patients with high platelet reactivity evaluated with VASP assay at 8:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity at 12:00 assessed with VASP
Number of patients with high platelet reactivity evaluated with VASP assay at 12:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity 16:00 assessed with VASP
Number of patients with high platelet reactivity evaluated with VASP assay at 16:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity 20:00 assessed with VASP
Number of patients with high platelet reactivity evaluated with VASP assay at 20:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity 08:00 assessed with Multiplate
Number of patients with high platelet reactivity evaluated with Multiplate at 08:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity 12:00 assessed with Multiplate
Number of patients with high platelet reactivity evaluated with Multiplate at 12:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity 16:00 assessed with Multiplate
Number of patients with high platelet reactivity evaluated with Multiplate at 16:00
Measured: Day 4 after acute myocardial infarction
High platelet reactivity 20:00 assessed with Multiplate
Number of patients with high platelet reactivity evaluated with Multiplate at 20:00
Measured: Day 4 after acute myocardial infarction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start26 Feb 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 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
- Jacek Kubica, Prof., Principal investigator, Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454841
- Sponsor's protocol ID
- CMUMK202I
- Acronym
- DRAGON
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2018
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Circadian Variability of Platelet Inhibition in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
- ClinicalTrials.gov ID
- NCT03454841
- Acronym / sponsor ID
- DRAGON / CMUMK202I
- Conditions
- Acute Myocardial Infarction
- Keywords
- prasugrel, ticagrelor, VASP, platelet reactivity, STEMI, NSTEMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Collegium Medicum w BydgoszczyUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 6 Mar 2018 (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 aim of this study is to compare circadian variability of antiplatelet effect of prasugrel and ticagrelor maintenance doses during the initial days after acute myocardial infarction.
Detailed description
Prasugrel and ticagrelor are two oral P2Y12 receptor antagonists recommended as a part of dual antiplatelet therapy with aspirin in patients with acute myocardial infarction. Both drugs exert comparable antiplatelet effect following a loading dose. However, pharmacodynamic differences exist between these P2Y12 receptor inhibitors. Prasugrel is a prodrug that requires hepatic activation and permanently binds to platelet P2Y12 receptors, whereas ticagrelor is an active drug and blocks P2Y12 receptors reversibly. Another important difference is that prasugrel maintenance dose is administered once daily, while ticagrelor requires next dosage every 12 hours. These fundamental distinctions may affect the degree of platelet inhibition on maintenance doses during the first days after acute myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prasugrel | – | Drug: PrasugrelPatients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin. |
| Ticagrelor | – | Drug: TicagrelorPatients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute myocardial infarction treated invasively.
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
- male or non-pregnant female, aged 18-75 years old
- provision of informed consent for angiography and percutaneous coronary intervention
Key exclusion criteria (14 listed)
- treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
- hypersensitivity to ticagrelor or prasugrel
- contraindications for ticagrelor or prasugrel
- current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
- active bleeding
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 |
|---|---|---|
| PrasugrelAlso: EfientPatients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily | Drug | Prasugrel |
| TicagrelorAlso: BriliquePatients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily | Drug | Ticagrelor |
Primary outcome
Circadian variability of platelet inhibition assessed with VASP
Time frame: Day 4 after acute myocardial infarction
Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00
Circadian variability of platelet inhibition assessed with Multiplate
Time frame: Day 4 after acute myocardial infarction
Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00
8 secondary outcomes
High platelet reactivity at 8:00 assessed with VASP
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity at 12:00 assessed with VASP
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity 16:00 assessed with VASP
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity 20:00 assessed with VASP
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity 08:00 assessed with Multiplate
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity 12:00 assessed with Multiplate
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity 16:00 assessed with Multiplate
Time frame: Day 4 after acute myocardial infarction
High platelet reactivity 20:00 assessed with Multiplate
Time frame: Day 4 after acute myocardial infarction
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 26 Feb 2020.
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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.
Jacek Kubica, Prof. principal investigator
Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by Collegium Medicum w Bydgoszczy at 2 sites 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 14 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Circadian variability of platelet inhibition assessed with VASP (time frame: Day 4 after acute myocardial infarction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2020.