DRAGON: Daily Variability of Platelet Aggregation in Patients With Myocardial Infarction Treated With Prasugrel and Ticagrelor
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prasugrel Patients with myocardial infarction will receive prasugrel as a part of dual antiplatelet therapy with aspirin. |
Drug: Prasugrel
Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily
Other Names:
|
| Ticagrelor Patients with myocardial infarction will receive ticagrelor as a part of dual antiplatelet therapy with aspirin. |
Drug: Ticagrelor
Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Circadian variability of platelet inhibition assessed with VASP [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 [Day 4 after acute myocardial infarction]
Platelet inhibition evaluated with Multiplate at 8:00, 12:00, 16:00 and 20:00
Secondary Outcome Measures
- High platelet reactivity at 8:00 assessed with VASP [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with VASP assay at 8:00
- High platelet reactivity at 12:00 assessed with VASP [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with VASP assay at 12:00
- High platelet reactivity 16:00 assessed with VASP [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with VASP assay at 16:00
- High platelet reactivity 20:00 assessed with VASP [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with VASP assay at 20:00
- High platelet reactivity 08:00 assessed with Multiplate [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with Multiplate at 08:00
- High platelet reactivity 12:00 assessed with Multiplate [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with Multiplate at 12:00
- High platelet reactivity 16:00 assessed with Multiplate [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with Multiplate at 16:00
- High platelet reactivity 20:00 assessed with Multiplate [Day 4 after acute myocardial infarction]
Number of patients with high platelet reactivity evaluated with Multiplate at 20:00
Eligibility Criteria
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
-
male or non-pregnant female, aged 18-75 years old
-
provision of informed consent for angiography and percutaneous coronary intervention
Exclusion Criteria:
-
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology, Wrocław Medical University | Wrocław | Dolnośląskie | Poland | 50-556 |
| 2 | Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University | Bydgoszcz | Kujawsko-pomorskie | Poland | 85-094 |
Sponsors and Collaborators
- Collegium Medicum w Bydgoszczy
Investigators
- Principal Investigator: Jacek Kubica, Prof., Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMUMK202I