Pulmonary EmbolismSTRATEGY-PENCT07603700
STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
An observational study of Pulmonary Embolism and Venous Thromboembolism, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This study aims to compare the effectiveness and safety of three treatment strategies (Anticoagulation, Thrombolysis, and Mechanical Thrombectomy) for patients with intermediate-high risk acute pulmonary embolism (PE) in a real-world setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Embolism, Venous Thromboembolism
- What is being tested?
- Anticoagulants, Thrombolytic Agents and Mechanical Thrombectomy Devices
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 31 Dec 2029
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with intermediate-high risk acute pulmonary embolism admitted to participating tertiary hospitals with Pulmonary Embolism Response Teams (PERT).
Who may be able to join
- Age unlimited (reflecting real-world population).
- Symptom duration of acute PE ≤ 14 days.
- Confirmed acute PE by CTPA involving main or lobar pulmonary arteries.
- Defined as Intermediate-High Risk PE meeting all of the following:
- RV/LV ratio ≥ 0.9 (by CT or Echocardiography).
- Elevated cardiac biomarkers (Troponin > 99th percentile or BNP > 100 pg/mL).
- Hemodynamically stable (SBP ≥ 90 mmHg, no vasopressors required).
- Able to provide informed consent and complete follow-up.
Who cannot join
- Already received thrombolysis or mechanical thrombectomy for the current episode prior to enrollment.
- Unable to obtain baseline or follow-up CTPA imaging.
- (Note: Unlike strict RCTs, patients with cancer, renal insufficiency, or advanced age are NOT excluded to ensure real-world representativeness).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Nanjing First Hospital
Nanjing, Jiangsu, 210006
Interventional Vascular Department Director, doctor, +86-25-52271000, kilogram@163.com
About this study
Official title: Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study
This study aims to compare the effectiveness and safety of three treatment strategies (Anticoagulation, Thrombolysis, and Mechanical Thrombectomy) for patients with intermediate-high risk acute pulmonary embolism (PE) in a real-world setting. Approximately 1,300 patients will be enrolled across multiple centers in China. Patients will be followed for 90 days to assess mortality, heart function recovery, bleeding risks, and quality of life. The results will help guide personalized treatment decisions and healthcare policy.
Read the detailed description
Background: Acute pulmonary embolism (PE) is a severe manifestation of venous thromboembolism (VTE). Intermediate-high risk PE accounts for 20-30% of all PE cases with significant mortality driven by right ventricular (RV) dysfunction. Current guidelines recommend anticoagulation for all, with thrombolysis or mechanical thrombectomy as rescue or alternative therapies. However, there is significant heterogeneity in real-world treatment selection and a lack of head-to-head comparative evidence among the three strategies in complex real-world populations.
Objective: To compare the 30-day and 90-day all-cause mortality and 48-hour RV/LV ratio improvement rate among three treatment strategies (Anticoagulation, Thrombolysis, Mechanical Thrombectomy) in patients with intermediate-high risk acute PE.
Design: This is a prospective, multicenter, non-randomized, pragmatic cohort study. Treatment allocation is based on routine clinical decision-making (natural allocation) without investigator intervention. Advanced statistical methods (Propensity Score Matching/Weighting, Instrumental Variable analysis) will be used to control for confounding factors.
Participants: 1,300 patients with confirmed acute intermediate-high risk PE (RV/LV ratio ≥0.9 and elevated cardiac biomarkers, hemodynamically stable). There are no age limits to reflect real-world diversity.
Interventions/Exposures:
- Anticoagulation (AC): Standard anticoagulant therapy (LMWH, DOAC, UFH, or Warfarin).
- Thrombolysis (TL): Systemic thrombolysis or Catheter-Directed Thrombolysis (CDT) using agents like Urokinase, Alteplase, etc.
- Mechanical Thrombectomy (MT): Mechanical removal of thrombus using FDA/NMPA approved devices (e.g., Indigo, FlowTriever, Acoscream), with or without adjunctive anticoagulation/thrombolysis.
Outcomes:
- Primary: 30-day and 90-day all-cause mortality; 48-hour RV/LV ratio improvement rate (≥15% reduction).
- Secondary: Clinical deterioration, major bleeding (ISTH/GUSTO/BARC), functional status (6MWT, NYHA, PVFS), quality of life (PEmb-QoL, EQ-5D-5L), PE recurrence, and healthcare resource utilization.
Follow-up: Patients will be followed at 48 hours, 7 days, 30 days, and 90 days.
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Being tested
- Anticoagulants, Thrombolytic Agents, Mechanical Thrombectomy Devices
- Keywords
- Acute Pulmonary Embolism, Intermediate-High Risk, Anticoagulation, Thrombolysis
- Medical subject headings
- Pulmonary Embolism, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulantsDrug
Also called Heparin, Enoxaparin, Rivaroxaban, Apixaban, Dabigatran, Edoxaban, Warfarin
Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens.
Thrombolytic AgentsDrug
Also called tPA, rt-PA, Urokinase, Tenecteplase
Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter.
Mechanical Thrombectomy DevicesDevice
Also called Indigo Aspiration System, FlowTriever, Acostream
Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.
| Study group | Role | What they receive |
|---|---|---|
| Anticoagulation Cohort | Patients receiving standard anticoagulation therapy alone without thrombolysis or mechanical thrombectomy. Receives: Drug: Anticoagulants | |
| Thrombolysis Cohort | Patients receiving systemic thrombolysis or catheter-directed thrombolysis. Receives: Device: Mechanical Thrombectomy Devices | |
| Mechanical Thrombectomy Cohort | Patients undergoing mechanical thrombectomy procedures using percutaneous devices. Receives: Drug: Thrombolytic Agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality at 30 Days
The percentage of participants who die from any cause within 30 days of enrollment.
Measured: 30 days
All-Cause Mortality at 90 Days
The percentage of participants who die from any cause within 90 days of enrollment.
Measured: 90 days
Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours
The proportion of participants with a reduction in RV/LV ratio ≥15% from baseline measured by CTPA or Echocardiography.
Measured: 48 hours ± 6 hours
Secondary outcomes (9)
Major Bleeding Events
Incidence of major bleeding defined by ISTH, GUSTO, or BARC criteria (including intracranial hemorrhage).
Measured: 48 hours, 7 days, 30 days, 90 days
Clinical Deterioration
Composite of hemodynamic instability, need for rescue therapy (escalation to thrombolysis/MT/ECMO), intubation, or PE-related death.
Measured: 48 hours, 7 days
6-Minute Walk Test (6MWT) Distance
Change in walking distance from baseline (estimated) to follow-up. Minimal Clinically Important Difference (MCID) ≥30 meters.
Measured: 30 days, 90 days
Post-VTE Functional Status (PVFS) Score
Assessment of functional limitation due to VTE (Scale 0-5).
Measured: 30 days, 90 days
Quality of Life (PEmb-QoL)
The questionnaire consists of 9 questions containing 40 items, which are organized into 6 domains:
Frequency of Complaints (FC): Assesses the frequency of respiratory and general symptoms (e.g., dyspnea, chest pain).
Daily Activity Limitations (AL): Measures limitations in performing activities of daily living (ADL).
Work-related Problems (WP): Evaluates difficulties in performing work or school duties.
Social Limitations (SL): Assesses restrictions on social activities. Intensity of Complaints (IC): Measures the severity of pain and breathlessness.
Emotional Complaints (EC): Captures anxiety, frustration, and fear related to the disease.
Measured: 90 days
Symptomatic PE Recurrence
Confirmed recurrent PE via CTPA or V/Q scan.
Measured: 90 days
ICU Length of Stay
Duration of intensive care unit stay during the index hospitalization
Measured: From ICU admission to ICU discharge, assessed up to 30 days
Total Hospital Length of Stay
Duration of index hospitalization from emergency department admission to hospital discharge
Measured: From hospital admission to hospital discharge, assessed up to 90 days
Total Medical Costs
Direct medical costs incurred during index hospitalization and within 90 days of enrollment, including medications, procedures, and hospitalization
Measured: Through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion31 Dec 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603700
- Sponsor's protocol ID
- KY20260205-04
- Acronym
- STRATEGY-PE
- Status last verified
- Jul 2025
- First submitted
- 24 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) and data dictionaries will be made available to researchers upon reasonable request after the publication of the primary results.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07603700
- Acronym / sponsor ID
- STRATEGY-PE / KY20260205-04
- Conditions
- Pulmonary Embolism, Venous Thromboembolism
- Keywords
- Acute Pulmonary Embolism, Intermediate-High Risk, Anticoagulation, Thrombolysis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 May 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.
This study aims to compare the effectiveness and safety of three treatment strategies (Anticoagulation, Thrombolysis, and Mechanical Thrombectomy) for patients with intermediate-high risk acute pulmonary embolism (PE) in a real-world setting. Approximately 1,300 patients will be enrolled across multiple centers in China. Patients will be followed for 90 days to assess mortality, heart function recovery, bleeding risks, and quality of life. The results will help guide personalized treatment decisions and healthcare policy.
Detailed description
Background: Acute pulmonary embolism (PE) is a severe manifestation of venous thromboembolism (VTE). Intermediate-high risk PE accounts for 20-30% of all PE cases with significant mortality driven by right ventricular (RV) dysfunction. Current guidelines recommend anticoagulation for all, with thrombolysis or mechanical thrombectomy as rescue or alternative therapies. However, there is significant heterogeneity in real-world treatment selection and a lack of head-to-head comparative evidence among the three strategies in complex real-world populations.
Objective: To compare the 30-day and 90-day all-cause mortality and 48-hour RV/LV ratio improvement rate among three treatment strategies (Anticoagulation, Thrombolysis, Mechanical Thrombectomy) in patients with intermediate-high risk acute PE.
Design: This is a prospective, multicenter, non-randomized, pragmatic cohort study. Treatment allocation is based on routine clinical decision-making (natural allocation) without investigator intervention. Advanced statistical methods (Propensity Score Matching/Weighting, Instrumental Variable analysis) will be used to control for confounding factors.
Participants: 1,300 patients with confirmed acute intermediate-high risk PE (RV/LV ratio ≥0.9 and elevated cardiac biomarkers, hemodynamically stable). There are no age limits to reflect real-world diversity.
Interventions/Exposures:
- Anticoagulation (AC): Standard anticoagulant therapy (LMWH, DOAC, UFH, or Warfarin).
- Thrombolysis (TL): Systemic thrombolysis or Catheter-Directed Thrombolysis (CDT) using agents like Urokinase, Alteplase, etc.
- Mechanical Thrombectomy (MT): Mechanical removal of thrombus using FDA/NMPA approved devices (e.g., Indigo, FlowTriever, Acoscream), with or without adjunctive anticoagulation/thrombolysis.
Outcomes:
- Primary: 30-day and 90-day all-cause mortality; 48-hour RV/LV ratio improvement rate (≥15% reduction).
- Secondary: Clinical deterioration, major bleeding (ISTH/GUSTO/BARC), functional status (6MWT, NYHA, PVFS), quality of life (PEmb-QoL, EQ-5D-5L), PE recurrence, and healthcare resource utilization.
Follow-up: Patients will be followed at 48 hours, 7 days, 30 days, and 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anticoagulation Cohort | – | Drug: AnticoagulantsPatients receiving standard anticoagulation therapy alone without thrombolysis or mechanical thrombectomy. |
| Thrombolysis Cohort | – | Device: Mechanical Thrombectomy DevicesPatients receiving systemic thrombolysis or catheter-directed thrombolysis. |
| Mechanical Thrombectomy Cohort | – | Drug: Thrombolytic AgentsPatients undergoing mechanical thrombectomy procedures using percutaneous devices. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with intermediate-high risk acute pulmonary embolism admitted to participating tertiary hospitals with Pulmonary Embolism Response Teams (PERT).
Key inclusion criteria (8 listed)
- Age unlimited (reflecting real-world population).
- Symptom duration of acute PE ≤ 14 days.
- Confirmed acute PE by CTPA involving main or lobar pulmonary arteries.
- Defined as Intermediate-High Risk PE meeting all of the following:
- RV/LV ratio ≥ 0.9 (by CT or Echocardiography).
Key exclusion criteria (3 listed)
- Already received thrombolysis or mechanical thrombectomy for the current episode prior to enrollment.
- Unable to obtain baseline or follow-up CTPA imaging.
- (Note: Unlike strict RCTs, patients with cancer, renal insufficiency, or advanced age are NOT excluded to ensure real-world representativeness).
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 |
|---|---|---|
| AnticoagulantsAlso: Heparin, Enoxaparin, Rivaroxaban, Apixaban, Dabigatran, Edoxaban, WarfarinLow Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens. | Drug | Anticoagulation Cohort |
| Thrombolytic AgentsAlso: tPA, rt-PA, Urokinase, TenecteplaseUrokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter. | Drug | Mechanical Thrombectomy Cohort |
| Mechanical Thrombectomy DevicesAlso: Indigo Aspiration System, FlowTriever, AcostreamAny FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal. | Device | Thrombolysis Cohort |
Primary outcome
All-Cause Mortality at 30 Days
Time frame: 30 days
The percentage of participants who die from any cause within 30 days of enrollment.
All-Cause Mortality at 90 Days
Time frame: 90 days
The percentage of participants who die from any cause within 90 days of enrollment.
Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours
Time frame: 48 hours ± 6 hours
The proportion of participants with a reduction in RV/LV ratio ≥15% from baseline measured by CTPA or Echocardiography.
9 secondary outcomes
Major Bleeding Events
Time frame: 48 hours, 7 days, 30 days, 90 days
Clinical Deterioration
Time frame: 48 hours, 7 days
6-Minute Walk Test (6MWT) Distance
Time frame: 30 days, 90 days
Post-VTE Functional Status (PVFS) Score
Time frame: 30 days, 90 days
Quality of Life (PEmb-QoL)
Time frame: 90 days
Symptomatic PE Recurrence
Time frame: 90 days
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, assessed up to 30 days
Total Hospital Length of Stay
Time frame: From hospital admission to hospital discharge, assessed up to 90 days
Total Medical Costs
Time frame: Through 90 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 22 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and data dictionaries will be made available to researchers upon reasonable request after the publication of the primary results.
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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.
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 Embolism and Venous Thromboembolism, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
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 8 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: opening soon, as of the sponsor's last update on 22 May 2026. 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 China. 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 he xu Dr, doctor (+86 153 6611 0045, kilogram@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality at 30 Days (time frame: 30 days). The study lists 3 primary outcomes in all. 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 22 May 2026.