Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

Sponsor
Drahomir Aujesky
Study ID
NCT04263038
Phase
PHASE4
Status
Recruiting
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Conditions

  • Anticoagulant-induced Bleeding
  • Bleeding
  • Cardiovascular Diseases
  • Embolism
  • Embolism and Thrombosis
  • Lung Diseases
  • Pulmonary Embolism
  • Respiratory Tract Diseases
  • Venous Thromboembolism

Eligibility Criteria

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

Interventions

  • Rivaroxaban — DRUG
    Anticoagulation
  • Placebo — DRUG
    Study drug without active agent

Study Details

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.

Key Dates

First listed
Feb 10, 2020
Start date
May 15, 2020
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
276 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Anticoagulation
    Patients in the anticoagulation group will receive rivaroxaban 15 mg twice daily for the first 21 days, followed by 20 mg once daily for an overall treatment duration of 90 days.
  • Placebo Comparator: No anticoagulation
    Patients in the group without anticoagulation will receive placebo twice daily for the first 21 days, followed by one tablet daily for an overall treatment duration of 90 days.

Primary Outcome Measure

Recurrent venous thromboembolism [ Time Frame: Within 90 days of randomization ]

Central Contacts

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