Status:
UNKNOWN
STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism
Lead Sponsor:
University of Birmingham
Collaborating Sponsors:
Royal United Hospitals Bath NHS Foundation Trust
Cimar
Conditions:
Subsegmental Pulmonary Embolism Nos
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Pulmonary embolisms (PE) occur when blood clots cause a blockage of the blood supply to the lungs. A small PE located in the subsegmental pulmonary vasculature is identified as a subsegmental PE (SSPE...
Eligibility Criteria
Inclusion
- Age ≥18 years
- SSPE diagnosed by the radiologist at the trial site by CTPA or CT thorax with IV contrast
- No evidence of proximal deep vein thrombosis on doppler ultrasonography or CT / Magnetic Resonance venography
- Heart rate (\<110bpm)
- Systolic blood pressure (≥100 mmHg)
- Oxygen saturation (≥90%)
- Written signed informed consent to the trial
Exclusion
- Indication for hospital admission
- \>7 days empirical anticoagulation treatment immediately prior to randomisation
- \<28 days since first symptoms of proven or clinically suspected Coronavirus disease (COVID-19)
- Known stage 5 chronic kidney disease
- Patients with active cancer defined as cancer diagnosed within the past 6 months, cancer for which anticancer treatment was being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced or metastatic cancer
- Patients with previous unprovoked PE, thrombophilia or requiring long term anticoagulation for another reason
- Patients with a Deep Vein Thrombosis / thrombus of an unusual site (e.g. upper limbs, associated with a line) that requires anticoagulation
- Patients with active bleeding
- Any condition which, in the opinion of the investigator, makes the participant unsuitable for trial entry due to prognosis/terminal illness with a projected survival of less than 3 months
- Pregnancy confirmed by positive pregnancy test or post-partum period or actively trying to conceive
- Inability to comply with the trial schedule and follow-up
- Participation in a Clinical Trial of Investigative Medicinal Product (CTIMP) study
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
1466 Patients enrolled
Trial Details
Trial ID
NCT04727437
Start Date
April 8 2021
End Date
May 1 2024
Last Update
September 29 2021
Active Locations (1)
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1
Surrey & Sussex Healthcare NHS Trust
Redhill, United Kingdom, RH1 5RH