Pulmonary EmbolismPhase 1PSCATNCT02946944
Sidlenafil in Combination With Oral Anticoagulants in Patients With Intermediate-high Risk of Pulmonary Embolism
A Phase 1 study testing Sildenafil/apixaban and apixaban in people with Pulmonary Embolism and Intermediate-high Risk, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Embolism, Intermediate-high Risk, Combination of Oral Anticoagulation Therapy and Sildenafil
- What is being tested?
- Sildenafil/apixaban and apixaban
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2016to Oct 2020
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pulmonary embolism confirmed by CT scan with contrast, with localization of thrombusa in at least one main or proximal lobar pulmonary artery.
- Right-left ventricular ratio (RV / LV) ≥1 derived from the apical four-chamber view
- Who gave written informed consent to participate in research
Who cannot join
- Age <18 or >80 years
- Symptoms of pulmonary embolism> 14 days
- Inadequate echocardiographic image quality in the apical four-chamber projection, which limits the measurement of RV / LV ratio
- A significant risk of bleeding
- The administration of thrombolytic drugs within the previous 4 days
- Active bleeding
Show all 26Show fewer
- Known coagulopathy
- Thrombocytopenia <100,10^9 / l
- Previous use of vitamin K antagonists with an INR> 2.5 at admission
- History of any intracranial or spinal surgery or trauma or intracranial / spinal bleeding
- Intracranial neoplasm
- Arteriovenous malformations or aneurysms
- GIH <3 months
- Cataract Surgery
- Obstetrical manipulation
- Cardiopulmonary resuscitation needed.
- Other invasive procedures <10 days
- Allergy, hypersensitivity, thrombocytopenia to heparin or tissue plasminogen activator
- Allergy to iodine contrast
- A well-known right-left cardiac shunt, for example, a large patent foramen ovale, or atrial septal defect; large (> 10 mm), or a blood clot in right atrium/right ventricle
- Systolic blood pressure <90 mm Hg for at least 15 minutes, or fall of systolic blood pressure is not less than 40 mm Hg for at least 15 min., with evidence of organ hypoperfusion (cold extremities or low diuresis <30 mL / h, or confusion), or the need for administration of catecholamines to maintain adequate perfusion of organs and systolic blood pressure> 90 mm Hg
- Severe hypertension (systolic> 180 mm Hg or diastolic> 105 mm Hg.).
- Pregnancy, lactation, delivery<30 days
- Participation in any other study (drug or device)
- Life expectancy <90 days
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Andrey Karpenko, MD/PhD contact
Alexey Cheban, MD contact
Russia1 site, 1 recruiting
- Recruiting
Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology
Novosibirsk, 630055
Artem Rabtsun, +79137078354, a_rabtsun@meshalkin.ru
About this study
Official title: Pilot Randomized Study of the Sidlenafil Efficacy in Combination With Oral Anticoagulants in the Treatment of Patients With Intermediate-high Risk of Pulmonary Embolism
Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
- Conditions
- Pulmonary Embolism, Intermediate-high Risk, Combination of Oral Anticoagulation Therapy and Sildenafil
- Being tested
- Sildenafil/apixaban, apixaban
- Keywords
- Pulmonary Embolism, sildenafil, oral anticoagulation therapy
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil/apixabanDrug
After arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups. Dual drug therapy is going to be administered to this group (experimental): sildenafil 30mg 3p \ g + 10 mg apixaban 2p \ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed .
apixabanDrug
After arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups.Mono drug therapy is going to be administered to this group (active comparator): apixaban 10 mg 2p \ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed .
| Study group | Role | What they receive |
|---|---|---|
| double drug therapy | Experimental | Not described Receives: Drug: Sildenafil/apixaban |
| mono drug therapy | Active comparator | Not described Receives: Drug: apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
MSCT RV \ LV Index
on the 7th day of treatment RV \ LV Index (calculated according to MSCT angiography of the pulmonary arteries)
Measured: 7th day
Secondary outcomes (9)
Echocardiogram RV \ LV Index
Echocardiogram (an index of RV \ LV) on 7th day
Measured: 7th day
Echocardiogram RV \ LV Index
Echocardiogram (an index of RV \ LV) on 14th day
Measured: 14th day
Echocardiogram RV \ LV Index
Echocardiogram (an index of RV \ LV) on one month
Measured: one month
Echocardiogram pressure in the pulmonary artery
the average pressure in the pulmonary artery according to echocardiography
Measured: one month
hemodynamic instability
in the hospital and within a month follow-up
Measured: one month
death
in the hospital and within a month follow-up
Measured: one month
bleeding
clinically significant bleeding on a scale HAS-BLED
Measured: one month
recurrent venous thrombosis
recurrent venous thrombosis
Measured: one month
recurrent pulmonary embolism
recurrent pulmonary embolism.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946944
- Sponsor's protocol ID
- NRICP-45734
- Acronym
- PSCAT
- Status last verified
- Oct 2016
- First submitted
- 20 Oct 2016
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Study of the Sidlenafil Efficacy in Combination With Oral Anticoagulants in the Treatment of Patients With Intermediate-high Risk of Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT02946944
- Acronym / sponsor ID
- PSCAT / NRICP-45734
- Conditions
- Pulmonary Embolism, Intermediate-high Risk, Combination of Oral Anticoagulation Therapy and Sildenafil
- Keywords
- Pulmonary Embolism, sildenafil, oral anticoagulation therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Oct 2016
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- 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.
Pilot randomized study of the sidlenafil efficacy in combination with oral anticoagulants in the treatment of patients with intermediate-high risk of pulmonary embolism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double drug therapy | Experimental | Drug: Sildenafil/apixaban |
| mono drug therapy | Active comparator | Drug: apixaban |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- pulmonary embolism confirmed by CT scan with contrast, with localization of thrombusa in at least one main or proximal lobar pulmonary artery.
- Right-left ventricular ratio (RV / LV) ≥1 derived from the apical four-chamber view
- Who gave written informed consent to participate in research
Key exclusion criteria (26 listed)
- Age <18 or >80 years
- Symptoms of pulmonary embolism> 14 days
- Inadequate echocardiographic image quality in the apical four-chamber projection, which limits the measurement of RV / LV ratio
- A significant risk of bleeding
- The administration of thrombolytic drugs within the previous 4 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil/apixabanAfter arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups. Dual drug therapy is going to be administered to this group (experimental): sildenafil 30mg 3p \ g + 10 mg apixaban 2p \ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed . | Drug | double drug therapy |
| apixabanAfter arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups.Mono drug therapy is going to be administered to this group (active comparator): apixaban 10 mg 2p \ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed . | Drug | mono drug therapy |
Primary outcome
MSCT RV \ LV Index
Time frame: 7th day
on the 7th day of treatment RV \ LV Index (calculated according to MSCT angiography of the pulmonary arteries)
9 secondary outcomes
Echocardiogram RV \ LV Index
Time frame: 7th day
Echocardiogram RV \ LV Index
Time frame: 14th day
Echocardiogram RV \ LV Index
Time frame: one month
Echocardiogram pressure in the pulmonary artery
Time frame: one month
hemodynamic instability
Time frame: one month
death
Time frame: one month
bleeding
Time frame: one month
recurrent venous thrombosis
Time frame: one month
recurrent pulmonary embolism
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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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.
Andrey Karpenko, MD/PhD contact
Alexey Cheban, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sildenafil/apixaban and apixaban in people with Pulmonary Embolism and Intermediate-high Risk, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 3 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. 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 Russia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey Karpenko, MD/PhD (a_karpenko@meshalkin.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MSCT RV \ LV Index (time frame: 7th day). 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 1 Nov 2016.