STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary Embolism

Sponsor
Nanjing First Hospital, Nanjing Medical University
Study ID
NCT07603700
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Pulmonary Embolism
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anticoagulants — DRUG
    Low Molecular Weight Heparin (LMWH), Direct Oral Anticoagulants (DOAC), Unfractionated Heparin (UFH), or Warfarin according to guideline-standard regimens.
  • Thrombolytic Agents — DRUG
    Urokinase, Pro-urokinase, Alteplase, or Tenecteplase administered systemically or via catheter.
  • Mechanical Thrombectomy Devices — DEVICE
    Any FDA/NMPA approved mechanical thrombectomy device (e.g., Indigo, FlowTriever, Acoscream) used for clot removal.

Study Details

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.

Key Dates

First listed
May 22, 2026
Start date
Jun 1, 2026
Status verified
Jul 2025
Primary completion
Mar 1, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
1,300 participants (estimated)

Arms

  • Arm: Anticoagulation Cohort
    Patients receiving standard anticoagulation therapy alone without thrombolysis or mechanical thrombectomy.
  • Arm: Thrombolysis Cohort
    Patients receiving systemic thrombolysis or catheter-directed thrombolysis.
  • Arm: Mechanical Thrombectomy Cohort
    Patients undergoing mechanical thrombectomy procedures using percutaneous devices.

Primary Outcome Measure

All-Cause Mortality at 30 Days [ Time Frame: 30 days ]

Central Contacts

Related Studies