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

NCT03454841 | Completed

• 1 other identifier: CMUMK202I
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Myocardial Infarction

Keywords

prasugrel; ticagrelor; VASP; platelet reactivity; STEMI; NSTEMI

Outcome Measures

Primary Outcomes (2)

• Circadian variability of platelet inhibition assessed with VASP

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

  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

  Day 4 after acute myocardial infarction

Secondary Outcomes (8)

• High platelet reactivity at 8:00 assessed with VASP

  Day 4 after acute myocardial infarction

• High platelet reactivity at 12:00 assessed with VASP

  Day 4 after acute myocardial infarction

• High platelet reactivity 16:00 assessed with VASP

  Day 4 after acute myocardial infarction

• High platelet reactivity 20:00 assessed with VASP

  Day 4 after acute myocardial infarction

• High platelet reactivity 08:00 assessed with Multiplate

  Day 4 after acute myocardial infarction

Study Arms (2)

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

Prasugrel DRUG

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

Prasugrel

Ticagrelor DRUG

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

Ticagrelor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute myocardial infarction treated invasively.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Collegium Medicum w Bydgoszczy: lead

Study Sites (2)

Department of Cardiology, Dr. A. Jurasz University Hospital, Collegium Medicum, Nicolaus Copernicus University

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-094, Poland

Location

Department of Cardiology, Wrocław Medical University

Wroclaw, Lower Silesian Voivodeship, 50-556, Poland

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction

Interventions

Prasugrel Hydrochloride; Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jacek Kubica, Prof.

  Department of Cardiology and Internal Medicine, Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr hab.

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: February 26, 2018
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

PL (2)