Pulmonary Embolism (Diagnosis)OPTIRAPENCT07436702
Optimal Time for Reperfusion in Acute Pulmonary Embolism
An observational study of Pulmonary Embolism (Diagnosis) and Pulmonary Embolism Acute, run by Azienda ULSS 8 Berica at 7 sites in Italy.
Trial summary
Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality worldwide. Current guidelines recommend early reperfusion for high-risk and intermediate-high-risk PE, yet systemic thrombolysis and percutaneous therapies are frequently underutilized, and no specific timing for reperfusion is defined… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (Diagnosis), Pulmonary Embolism Acute
- How many people
- 500 participants
- Where
- 7 sitesItaly
- Study dates
- 25 Nov 2025to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed diagnosis of high-risk or intermediate-high-risk pulmonary embolism according to the 2019 European Society of Cardiology guidelines.
Who may be able to join
- Age ≥ 18 years
- Patients with a diagnosis of intermediate-high or high pulmonary embolism confirmed by computed tomography pulmonary angiography (CTPA), pulmonary angiography, or echocardiography (evidence of a floating thrombus in the right atrium or right ventricle, or proximal visualization of thrombus in the pulmonary artery).
- Classified as high-risk or intermediate-high-risk according to the 2019 European Society of Cardiology guidelines.
- Provision of informed consent for the processing of personal data.
Who cannot join
- Age < 18 years
- Patients in whom a diagnosis of acute high-risk or intermediate-high-risk pulmonary embolism has been excluded.
- Inability to provide informed consent.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
UOC di Cardiologia, Ospedali dell'Ovest Vicentino, Arzignano, IItalia
Arzignano, Vicenza, 36071
Claudio Bilato, MD PhD, +390444931163, claudio.bilato@aulss8.veneto.it
Claudio Bilato, MD PhD
- Recruiting
UO Unità di Cure Intensive Cardiologiche e Cardiologia 1, Ospedale Niguarda, Milano
Milan, Milano, 20162
Claudia Colombo, MD, +390264442565, claudia.colombo@ospealeniguarda.it
Claudia Colombo, MD
- Recruiting
UOC di Cardiologia, Ospedali Riuniti Padova Sud, Monselice, Italia
Monselice, Padova, 35043
Marco Zuin, MD MS, +390429715631, marco.zuin@aulss6.veneto.it
- Recruiting
IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Leonardo De Luca, MD PhD, +390382503158, l.deluca@smatteo.pv.it
Leonardo De Luca, MD PhD
- Recruiting
UO di Sezione di Medicina Interna e Cardiovascolare, Ospedale Santa Maria della Misericordia, Perugia, Italia
Perugia, Perugia, 06129
Cecilia Becattini, MD PhD, +390755786424, cecilia.becattini@unipg.it
Maria Cristina Vedovati, MD PhD
- Recruiting
UO di Cardiologia 1, Azienda Ospedaliero Universitaria Pisana, Pisa, Italia
Pisa, Pisa, 56126
Rosalinda Madonna, MD PhD, +39050996975, rosalinda.madonna@unipi.it
Rosalinda Madonna, MD PhD
- Recruiting
UO di Cardiologia, Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Torino, 10128
Giuseppe Musumeci, MD, +390115082515, giuseppe.musumeci@gmail.com
Giuseppe Musumeci, MD
About this study
Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality worldwide. Current guidelines recommend early reperfusion for high-risk and intermediate-high-risk PE, yet systemic thrombolysis and percutaneous therapies are frequently underutilized, and no specific timing for reperfusion is defined, unlike in acute myocardial infarction or ischemic stroke. As most PE-related in-hospital deaths occur within the first hours and thrombus composition changes over time, defining an optimal reperfusion time window may improve survival and prevent hemodynamic deterioration. We therefore propose a national, multicenter, prospective observational study to evaluate the prognostic impact of reperfusion timing, using systemic thrombolysis or catheter-directed therapies, on in-hospital mortality and haemorrhagic or cardiovascular complications.
Read the detailed description
Pulmonary embolism (PE) is currently the third leading cause of cardiovascular mortality worldwide. According to international guidelines, patients who are hemodynamically unstable at presentation (classified as high-risk according to the current European Society of Cardiology classification) and those at intermediate-high risk-defined as patients who are hemodynamically stable at admission but present with right ventricular dysfunction and positive cardiac ischemia biomarkers and subsequently develop sudden hemodynamic deterioration, should undergo reperfusion as early as possible.
At present, reperfusion in these patients is mainly achieved through systemic thrombolysis or percutaneous treatments. However, these strategies are frequently underutilized because of patients' comorbidities and bleeding risk. Notably, current international guidelines do not define a specific time window within which reperfusion should be performed using either approach, in contrast to what is well established in guidelines for acute myocardial infarction and ischemic stroke.
Given that most in-hospital deaths related to PE occur within the first hours after symptom onset and hospital admission, and considering that the histological composition of thrombi undergoes time-dependent changes that may partially reduce the effectiveness of reperfusion therapies, identifying a temporal cutoff within which reperfusion confers maximal clinical benefit would be highly relevant. Such a cutoff could improve both patient survival and the prevention of hemodynamic deterioration when performing systemic or percutaneous reperfusion.
To address this knowledge gap, we propose a national, multicenter, prospective observational study that could also could serve as a platform for registry-based randomized clinical trials. The primary aim of the study is to identify optimal management strategies for patients with intermediate-high-risk or high-risk PE, with a particular focus on the most appropriate timing of systemic reperfusion or catheter-directed therapies (CDTs), when indicated, and to evaluate their prognostic impact. Specifically, the study will assess the relationship between reperfusion timing (systemic thrombolysis or CDTs) and in-hospital mortality. Additionally, the association between different reperfusion time windows and the occurrence of haemorrhagic or cardiovascular complications will be evaluated.
- Keywords
- Fibrinolysis, Anticoagulation, Catheter-directed treatments, Time of Reperfusion
- Medical subject headings
- Pulmonary Embolism, Disease
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 |
|---|---|---|
| Patients with intermediate-high or high-risk pulmonary embolism | Patients with intermediate-high or high-risk pulmonary embolism stratified according to the ESC 2019 guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Correlation between time to reperfusion (measured in hours from hospital admission to initiation of systemic thrombolysis or catheter-directed therapies [CDTs]) and in-hospital mortality rate (rate of patients) among patients with intermediate-high- and high-risk acute pulmonary embolism.
Measured: From enrollment to the end of treatment at 30 days
Secondary outcomes (1)
Complications
Association between different reperfusion time windows and techniques and the occurrence of haemorrhagic or cardiovascular complications among patients with intermediate-high and high-risk with acute pulmonary embolism
Measured: From enrollment to the end of treatment at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start25 Nov 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism (Diagnosis)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda ULSS 8 Berica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco Zuin, MD MS, Study director, Department of Translational Medicine, University of Ferrara, ItalyClaudio Bilato, MD PhD, Principal investigator, Department of Cardiology, Azienda AULSS 8 Berica, Arzignano (Vicenza), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436702
- Sponsor's protocol ID
- OPTIRAPE - 775CET 2026
- Acronym
- OPTIRAPE
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Time for Reperfusion in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT07436702
- Acronym / sponsor ID
- OPTIRAPE / OPTIRAPE - 775CET 2026
- Keywords
- Fibrinolysis, Anticoagulation, Catheter-directed treatments, Time of Reperfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azienda ULSS 8 BericaUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (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.
Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality worldwide. Current guidelines recommend early reperfusion for high-risk and intermediate-high-risk PE, yet systemic thrombolysis and percutaneous therapies are frequently underutilized, and no specific timing for reperfusion is defined, unlike in acute myocardial infarction or ischemic stroke. As most PE-related in-hospital deaths occur within the first hours and thrombus composition changes over time, defining an optimal reperfusion time window may improve survival and prevent hemodynamic deterioration. We therefore propose a national, multicenter, prospective observational study to evaluate the prognostic impact of reperfusion timing, using systemic thrombolysis or catheter-directed therapies, on in-hospital mortality and haemorrhagic or cardiovascular complications.
Detailed description
Pulmonary embolism (PE) is currently the third leading cause of cardiovascular mortality worldwide. According to international guidelines, patients who are hemodynamically unstable at presentation (classified as high-risk according to the current European Society of Cardiology classification) and those at intermediate-high risk-defined as patients who are hemodynamically stable at admission but present with right ventricular dysfunction and positive cardiac ischemia biomarkers and subsequently develop sudden hemodynamic deterioration, should undergo reperfusion as early as possible.
At present, reperfusion in these patients is mainly achieved through systemic thrombolysis or percutaneous treatments. However, these strategies are frequently underutilized because of patients' comorbidities and bleeding risk. Notably, current international guidelines do not define a specific time window within which reperfusion should be performed using either approach, in contrast to what is well established in guidelines for acute myocardial infarction and ischemic stroke.
Given that most in-hospital deaths related to PE occur within the first hours after symptom onset and hospital admission, and considering that the histological composition of thrombi undergoes time-dependent changes that may partially reduce the effectiveness of reperfusion therapies, identifying a temporal cutoff within which reperfusion confers maximal clinical benefit would be highly relevant. Such a cutoff could improve both patient survival and the prevention of hemodynamic deterioration when performing systemic or percutaneous reperfusion.
To address this knowledge gap, we propose a national, multicenter, prospective observational study that could also could serve as a platform for registry-based randomized clinical trials. The primary aim of the study is to identify optimal management strategies for patients with intermediate-high-risk or high-risk PE, with a particular focus on the most appropriate timing of systemic reperfusion or catheter-directed therapies (CDTs), when indicated, and to evaluate their prognostic impact. Specifically, the study will assess the relationship between reperfusion timing (systemic thrombolysis or CDTs) and in-hospital mortality. Additionally, the association between different reperfusion time windows and the occurrence of haemorrhagic or cardiovascular complications will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with intermediate-high or high-risk pulmonary embolism | – | –Patients with intermediate-high or high-risk pulmonary embolism stratified according to the ESC 2019 guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed diagnosis of high-risk or intermediate-high-risk pulmonary embolism according to the 2019 European Society of Cardiology guidelines.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Patients with a diagnosis of intermediate-high or high pulmonary embolism confirmed by computed tomography pulmonary angiography (CTPA), pulmonary angiography, or echocardiography (evidence of a floating thrombus in the right atrium or right ventricle, or proximal visualization of thrombus in the pulmonary artery).
- Classified as high-risk or intermediate-high-risk according to the 2019 European Society of Cardiology guidelines.
- Provision of informed consent for the processing of personal data.
Key exclusion criteria (3 listed)
- Age < 18 years
- Patients in whom a diagnosis of acute high-risk or intermediate-high-risk pulmonary embolism has been excluded.
- Inability to provide informed consent.
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
Mortality
Time frame: From enrollment to the end of treatment at 30 days
Correlation between time to reperfusion (measured in hours from hospital admission to initiation of systemic thrombolysis or catheter-directed therapies [CDTs]) and in-hospital mortality rate (rate of patients) among patients with intermediate-high- and high-risk acute pulmonary embolism.
1 secondary outcome
Complications
Time frame: From enrollment to the end of treatment at 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Marco Zuin, MD MS study director
Department of Translational Medicine, University of Ferrara, Italy
Claudio Bilato, MD PhD principal investigator
Department of Cardiology, Azienda AULSS 8 Berica, Arzignano (Vicenza), Italy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism (Diagnosis) and Pulmonary Embolism Acute, run by Azienda ULSS 8 Berica at 7 sites in Italy.
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 3 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Bilato, MD PhD (+390444479106, claudio.bilato@aulss8.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From enrollment to the end of treatment at 30 days). 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 3 Mar 2026.