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.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Warsaw、ポーランド
- Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, Centre of Postgraduate Education Medical, European Health Centre Otwock
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Platelet reactivity
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Concentration of extracellular vesicles from platelets, leukocytes and endothelial cells
時間枠: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
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。