STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism
China1,300 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All-Cause Mortality at 30 Days
Timeframe: 30 days
2
All-Cause Mortality at 90 Days
Timeframe: 90 days
3
Right Ventricular to Left Ventricular (RV/LV) Ratio Improvement Rate at 48 Hours
Timeframe: 48 hours ± 6 hours
Trial details
NCT IDNCT07603700
SponsorNanjing First Hospital, Nanjing Medical University