STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
STRATEGY-PE
Real-World Comparative Effectiveness and Safety of Anticoagulation, Thrombolysis, and Mechanical Thrombectomy in Intermediate-Risk Acute Pulmonary Embolism: A Multicenter Prospective Cohort Study
1 other identifier
observational
1,300
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2026
CompletedFirst Posted
Study publicly available on registry
May 22, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2029
May 22, 2026
July 1, 2025
1.8 years
March 24, 2026
May 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
All-Cause Mortality at 30 Days
The percentage of participants who die from any cause within 30 days of enrollment.
30 days
All-Cause Mortality at 90 Days
The percentage of participants who die from any cause within 90 days of enrollment.
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.
48 hours ± 6 hours
Secondary Outcomes (9)
Major Bleeding Events
48 hours, 7 days, 30 days, 90 days
Clinical Deterioration
48 hours, 7 days
6-Minute Walk Test (6MWT) Distance
30 days, 90 days
Post-VTE Functional Status (PVFS) Score
30 days, 90 days
Quality of Life (PEmb-QoL)
90 days
- +4 more secondary outcomes
Other Outcomes (2)
Biomarker Improvement (Troponin, BNP, D-Dimer)
48 hours, 7 days
Daily Step Count
Continuous monitoring through 90 days
Study Arms (3)
Anticoagulation Cohort
Patients receiving standard anticoagulation therapy alone without thrombolysis or mechanical thrombectomy.
Thrombolysis Cohort
Patients receiving systemic thrombolysis or catheter-directed thrombolysis.
Mechanical Thrombectomy Cohort
Patients undergoing mechanical thrombectomy procedures using percutaneous devices.
Interventions
Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens.
Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter.
Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.
Eligibility Criteria
Patients diagnosed with intermediate-high risk acute pulmonary embolism admitted to participating tertiary hospitals with Pulmonary Embolism Response Teams (PERT).
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Biospecimen
Blood samples collected for routine laboratory tests (Troponin, BNP, D-Dimer, Coagulation profile) during hospitalization and follow-up. No DNA extraction or biobanking planned.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2026
First Posted
May 22, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
May 22, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Starting 6 months after publication of the primary results, available for 5 years.
- Access Criteria
- Data will be shared with researchers who provide a methodologically sound proposal and whose use of data is for legitimate research purposes. Requests should be directed to the Principal Investigator.
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.