- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04578223
Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension (PAPAYA)
Background: Prostacyclin analogues (epoprostenol, treprostinil and iloprost) induce vasodilation in advanced pulmonary arterial hypertension (PAH) but also inhibit platelets, increasing patients' bleeding risk. The antiplatelet effects of different prostacyclin analogues have never been compared head-to-head. The goal of the PAPAYA (Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension) trial is(i) to compare platelet function (platelet reactivity, extracellular vesicles concentration and thrombus formation) in patients with PAH treated with prostacyclin analogues on top of endothelin receptor antagonists (ERA) and/or phosphodiesterase type 5 inhibitors (PDE5i) and patients treated only with ERA and PDE5i, and (ii) to compare the antiplatelet effect of different prostacyclin analogues.
Venous blood will be collected from patients treated with prostacyclin analogues (study group; n=40) and patients treated with ERA or PDE5i (control group; n=40). Platelet reactivity will be analysed in whole blood by impedance aggregometry using arachidonic acid, adenosine diphosphate and thrombin receptor-activating peptide as agonists. Concentrations of extracellular vesicles from all platelets (CD61+), activated platelets (CD62P+), leukocytes (CD45+) and endothelial cells (CD146+) will be analysed in platelet-depleted plasma using flow cytometry (A-60 Micro). Platelet-rich thrombus formation will be measured using whole blood perfusion system. The study will determine the antiplatelet effect of prostacyclin analogues and compare different prostacyclin analogues head-to-head to identify the best drugs to use in case of thrombosis or bleeding.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Warsaw, Polen
- Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, Centre of Postgraduate Education Medical, European Health Centre Otwock
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Informed consent to participate in the study
- Pulmonary arterial hypertension confirmed with right heart catheterization
- Treatment with prostacyclin analogues (epoprostenol, treprostinil, iloprost) - study group
- Treatment with endothelin receptor antagonists and phosphodiesterase type 5 inhibitors - control group
Exclusion Criteria:
- Known coagulopathy
- Active pathological bleeding
- Known history of bleeding disorder
- Severe thrombocytopenia (platelet count < 50,000/μL )
- Need for antiplatelet therapy with acetylsalicylic acid or P2Y12 antagonists
- Severe chronic renal failure (estimated glomerular filtration rate < 30 mL/min)
- Severe liver insufficiency (Child-Pugh class C)
- Known pregnancy, breast-feeding, or intention to become pregnant during the study period
- Study drug intolerance
- Participation in any previous study with prostacyclin analogues
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Study group
Patients with pulmonary arterial hypertension treated with prostacyclin analogues on top of ERA or PDE-5i.
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Control group
Patients with pulmonary arterial hypertension treated with ERA or PDE-5i only.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Platelet reactivity
Tidsram: July 5, 2017 - November 30, 2019
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Difference in platelet reactivity between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5-i, assessed using impedance aggregometry
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July 5, 2017 - November 30, 2019
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Concentration of extracellular vesicles from platelets, leukocytes and endothelial cells
Tidsram: July 5, 2017 - November 30, 2019
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Differences in concentration of extracellular vesicles from platelets, leukocytes and endothelial cells between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5i, assessed using flow cytometry
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July 5, 2017 - November 30, 2019
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Platelet-rich thrombus formation parameters
Tidsram: July 5, 2017 - November 30, 2019
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Differences in platelet-rich thrombus formation parameters between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5i, assessed using whole-blood flow-chamber perfusion system
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July 5, 2017 - November 30, 2019
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KB/138/217
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