Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04578223
Status:
COMPLETED
Last Update Posted:
2020-10-09
First Post:
2020-09-30
Brief Title:
Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension
Sponsor:
Medical University of Warsaw
Organization:
Medical University of Warsaw
Study Overview
Official Title:
Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAPAYA
Brief Summary:
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 isi 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 andor 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 n40 and patients treated with ERA or PDE5i control group n40 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
Venous blood will be collected from patients treated with prostacyclin analogues study group n40 and patients treated with ERA or PDE5i control group n40 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None