STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism

Launched by UNIVERSITY OF BIRMINGHAM · Jan 25, 2021

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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