Pulmonary HypertensionPAPAYANCT04578223
Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension
An observational study of Pulmonary Hypertension, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Hypertension
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- 5 Jul 2017to 23 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Patients were eligible for enrolment if they (i) had PAH diagnosed according to the criteria of European Society of Cardiology and European Respiratory Society, confirmed during right heart catheterization, (ii) were treated with prostacyclin analogues on top of other drugs (study group) or only other drugs (ERA and PDE-5i; control group) for at least 1 month.
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pulmonary Circulation, Thromboembolic Diseases and Cardiology, Centre of Postgraduate Education Medical, European Health Centre Otwock
Warsaw
About this study
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.
- Conditions
- Pulmonary Hypertension
- Keywords
- prostacyclin analogues, pulmonary arterial hypertension, platelet reactivity, extracellular vesicles, thrombus formation
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients with pulmonary arterial hypertension treated with prostacyclin analogues on top of ERA or PDE-5i. | |
| Control group | Patients with pulmonary arterial hypertension treated with ERA or PDE-5i only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet reactivity
Difference in platelet reactivity between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5-i, assessed using impedance aggregometry
Measured: July 5, 2017 - November 30, 2019
Secondary outcomes (2)
Concentration of extracellular vesicles from platelets, leukocytes and endothelial cells
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
Measured: July 5, 2017 - November 30, 2019
Platelet-rich thrombus formation parameters
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
Measured: July 5, 2017 - November 30, 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start5 Jul 2017
- Primary completion30 Nov 2019
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- European Health Centre Otwock
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578223
- Sponsor's protocol ID
- KB/138/217
- Acronym
- PAPAYA
- Status last verified
- Sep 2020
- First submitted
- 30 Sep 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity and Treatment With Prostacyclin Analogues in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04578223
- Acronym / sponsor ID
- PAPAYA / KB/138/217
- Conditions
- Pulmonary Hypertension
- Keywords
- prostacyclin analogues, pulmonary arterial hypertension, platelet reactivity, extracellular vesicles, thrombus formation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- European Health Centre Otwock
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients with pulmonary arterial hypertension treated with prostacyclin analogues on top of ERA or PDE-5i. |
| Control group | – | –Patients with pulmonary arterial hypertension treated with ERA or PDE-5i only. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients were eligible for enrolment if they (i) had PAH diagnosed according to the criteria of European Society of Cardiology and European Respiratory Society, confirmed during right heart catheterization, (ii) were treated with prostacyclin analogues on top of other drugs (study group) or only other drugs (ERA and PDE-5i; control group) for at least 1 month.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Platelet reactivity
Time frame: July 5, 2017 - November 30, 2019
Difference in platelet reactivity between patients treated with prostacyclin analogues and treated with ERA and/ or PDE5-i, assessed using impedance aggregometry
2 secondary outcomes
Concentration of extracellular vesicles from platelets, leukocytes and endothelial cells
Time frame: July 5, 2017 - November 30, 2019
Platelet-rich thrombus formation parameters
Time frame: July 5, 2017 - November 30, 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet reactivity (time frame: July 5, 2017 - November 30, 2019). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.