Three-arm treatment test for intermediate-high risk pulmonary embolism in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

STRATIFY II is a regional randomized trial that compares three approaches for acute intermediate-high risk PE: catheter-based embolectomy, low-dose rtPA thrombolysis, and heparin alone with optional thrombolysis. Patients are randomized 1:1:1 to receive treatment within 12 hours of randomization, with thrombus burden measured at 48–96 hours as a key endpoint. The study aims to determine whether catheter-based strategies reduce thrombus more effectively than heparin alone and whether embolectomy offers greater burden reduction than low-dose thrombolysis. Primary outcomes focus on thrombus burden changes and comparative efficacy among the three arms. The trial is designed to balance efficacy with bleeding and other safety risks in this population.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

1. Age ≥ 18 years
2. Intermediate high-risk PE according to ESC criteria
3. Class II risk assessed by the Pulmonary Embolism Severity Index (1).
4. Thrombus visible in main, lobar or segmental pulmonary arteries on CT angiography
5. 14 days of symptoms or less, with significant worsening of symptoms within 7 days

EXCLUSION CRITERIA

1. Altered mental state (GCS \< 14)
2. No qualifying CT angiography performed (\> 24 hour since CT angiography)
3. Women of childbearing potential, unless negative HCG test is present.
4. Thrombolysis for PE within 14 days of randomization
5. Thrombus passing through patent Foramen Ovale (risk of paradoxical embolism)
6. Ongoing oral anticoagulation therapy (heparins, aspirin, antiplatelet therapy and NOAC allowed)
7. Comorbidity making 6 months survival unlikely.
8. Absolute contraindications for thrombolysis:

   1. History of haemorrhagic stroke or stroke of unknown origin
   2. Ischaemic stroke in previous 6 months
   3. Central nervous system neoplasm
   4. Major trauma, surgery, or head injury in previous 3 weeks
   5. Bleeding diathesis - Active bleeding

Where it's running

• Copenhagen University Hospital Rigshospitalet
  Copenhagen, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Not yet recruiting

Study contacts

• Study coordinator: Jesper Kjaergaard, MD PhD DMSc
• Email: jesper.kjaergaard.05@regionh.dk
• Phone: +4535450969

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.