NCT04727437

STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,466 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). Anticoagulants are used to treat SSPE and work by preventing new clots from forming whilst the body's own mechanisms break down the clots, however they can also increase the risk of major and potentially life threatening bleeding. More recent observational data of routine care for SSPE showed very high complication rates of anticoagulation but in patients where treatment was withheld, this proved to be a safe strategy in terms of recurrent venous thromboembolism (VTE). Computed tomography pulmonary angiography (CTPA) scans are now able to detect SSPE, however there are concerns that there is an over-diagnosis due to the incorrect interpretation of small artefacts. 1466 patients from approximately 50 sites will be recruited, these sites will consist of hospitals across the United Kingdom (UK). Patients 18 and over with isolated SSPE, confirmed by either CTPA or CT thorax with IV contrast, will be eligible for the trial. Patients will be randomised to either receive standard anticoagulation for at least 3 months (control) or no anticoagulation for at least 3 months (intervention). The participant will receive telephone follow up calls at 4, 12 and 24 weeks following the end of their treatment, and additional data will also be taken from their medical records at these time points. The participant isn't required to be contacted for the 52 week follow up as the data will be extracted from the National Health Service (NHS) Digital collection of Hospital Episode Statistics (HES). In total participation in the study will last 12 months. In addition the cost-effectiveness of no treatment versus treatment with full anticoagulation will be looked at and also improving on radiological diagnosis of SSPE.

Conditions

• Subsegmental Pulmonary Embolism Nos

Interventions

Type	Name	Description
OTHER	No treatment	Withholding anticoagulation for at least 3 months.
DRUG	Warfarin	anticoagulation drug given for at least 3 months.
DRUG	direct oral anticoagulants	anticoagulation drug given for at least 3 months.
DRUG	Low molecular weight heparin	anticoagulation drug, subcutaneous injection given for at least 3 months.

Timeline

• Start date: 2021-04-08
• Primary completion: 2023-07-01
• Completion: 2024-05-01
• First posted: 2021-01-27
• Last updated: 2021-09-29

Locations

1 site across 1 country: United Kingdom