ClinicalTrials.gg
CompletedNCT03454841DRAGONUpdated Feb 26, 2020

Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor

An observational study in Acute Myocardial Infarction, sponsored by Collegium Medicum w Bydgoszczy. Completed at 2 sites in Poland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Collegium Medicum w Bydgoszczy · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 30 studies in ST Elevation Myocardial Infarction with a site in Poland — 3 open to participants now, 4 under way, 2 of them phase 3. ST Elevation Myocardial Infarction · Poland.

Started
2018
with 2 others
Observational
7 of 30
1 open now
Registered
18th of 30
by date
Lead sponsor
5 of 30
Collegium Medicum w Bydgoszczy

Among the 30 studies in ST Elevation Myocardial Infarction with a site in Poland, this one is one of 3 that started in 2018, is one of 7 observational ones, and was the 18th registered.

ST Elevation Myocardial Infarction

851 studies on the registry are indexed under ST Elevation Myocardial Infarction; 198 are open to participants now.

Browse ST Elevation Myocardial Infarction studies →

Open to participants now

3 of the 30 studies in ST Elevation Myocardial Infarction with a site in Poland are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Poland have not opened yet or have stopped. Only those recruiting at a site in Poland →

Who these studies take

Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in ST Elevation Myocardial Infarction with a site in Poland, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Acute Myocardial Infarction

Keywords

  • prasugrel
  • ticagrelor
  • VASP
  • platelet reactivity
  • STEMI
  • NSTEMI
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with acute myocardial infarction treated invasively.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • provision of 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

Exclusion criteria

Exclusion Criteria:

  • treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment
  • to ticagrelor or prasugrel
  • for ticagrelor or prasugrel
  • current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin
  • active bleeding
  • history of ischemic stroke or
  • 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 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (actual)
Patient registry
No

Groups and cohorts

  • Prasugrel

    Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin.

    Drug: Prasugrel

  • Ticagrelor

    Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin.

    Drug: Ticagrelor

Interventions

  • Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily

    Also known as: Efient

  • Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily

    Also known as: Brilique

06

What researchers measure

Primary outcomes

  1. Circadian variability of platelet inhibition assessed with VASP

    Platelet inhibition evaluated with VASP assay at 8:00, 12:00, 16:00 and 20:00

    Time frame: Day 4 after acute myocardial infarction

  2. Circadian variability of platelet inhibition assessed with Multiplate

    Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00

    Time frame: Day 4 after acute myocardial infarction

Secondary outcomes

  1. High platelet reactivity at 8:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 8:00

    Time frame: Day 4 after acute myocardial infarction

  2. High platelet reactivity at 12:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 12:00

    Time frame: Day 4 after acute myocardial infarction

  3. High platelet reactivity 16:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 16:00

    Time frame: Day 4 after acute myocardial infarction

  4. High platelet reactivity 20:00 assessed with VASP

    Number of patients with high platelet reactivity evaluated with VASP assay at 20:00

    Time frame: Day 4 after acute myocardial infarction

  5. High platelet reactivity 08:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 08:00

    Time frame: Day 4 after acute myocardial infarction

  6. High platelet reactivity 12:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 12:00

    Time frame: Day 4 after acute myocardial infarction

  7. High platelet reactivity 16:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 16:00

    Time frame: Day 4 after acute myocardial infarction

  8. High platelet reactivity 20:00 assessed with Multiplate

    Number of patients with high platelet reactivity evaluated with Multiplate at 20:00

    Time frame: Day 4 after acute myocardial infarction

07

Study locations

2 sites
  • Department of Cardiology, Wrocław Medical University
    Wrocław, Dolnośląskie 50-556, Poland
  • Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University
    Bydgoszcz, Kujawsko-pomorskie 85-094, Poland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Feb 2019, 12 months.

Of 122 non-industry observational studies under ST Elevation Myocardial Infarction, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 107. This study's 12 months is below that.

Counting every sponsor, half of 143 studies reached it within 38 months; a quarter within 20 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2018
First posted
Mar 6, 2018
StartActual
Feb 26, 2018
Primary completionActual
Feb 28, 2019
CompletionActual
Feb 28, 2019
Last update
Feb 26, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03454841
Lead sponsor
Collegium Medicum w Bydgoszczy
Responsible party
Jacek Kubica (Prof. dr hab., Collegium Medicum w Bydgoszczy) — Principal investigator
First posted
Mar 6, 2018
Start date
Feb 26, 2018
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Feb 26, 2020

Study contacts

Jacek Kubica, Prof.
principal investigator · Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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