What is rivaroxaban studying for pulmonary embolism?

Rivaroxaban is being studied to see if it is needed for treating low-risk patients with isolated subsegmental pulmonary embolism (SSPE). Researchers want to find out if monitoring patients without anticoagulation is as safe as using rivaroxaban. This trial is sponsored by Drahomir Aujesky and aims to improve treatment decisions for SSPE.

Who may be eligible for this pulmonary embolism clinical trial?

Adults aged 18 years or older with a diagnosis of isolated SSPE may be eligible. The study includes all genders but excludes those with deep vein thrombosis, active cancer, or recent anticoagulation treatment. Please review eligibility criteria for more details.

Is there any cost to participate in this pulmonary embolism clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or related costs.

Actively Recruiting

Phase 4

Age: 18Years +

All Genders

ID04263038

Comparing Clinical Surveillance and Anticoagulation Treatment for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism

Led by Drahomir Aujesky · Updated on 2026-05-22

276

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the best approach to treat low-risk patients with isolated subsegmental pulmonary embolism SSPE, a type of blood clot in small lung arteries. The study aims to determine whether monitoring patients without anticoagulation is as safe and effective as giving anticoagulant medication. This is important because many patients currently receive anticoagulants that carry a risk of bleeding, but it is unclear if all patients with isolated SSPE need this treatment. Patients in the trial are randomly assigned to one of two groups. One group receives the anticoagulant drug rivaroxaban, starting with 15 mg twice daily for 21 days, then 20 mg once daily for a total of 90 days. The other group receives a placebo matching the same schedule. The trial compares clinical surveillance without anticoagulation to anticoagulation treatment to assess safety and effectiveness. Participants will be followed for 90 days after randomization to monitor for recurrent venous thromboembolism, significant bleeding events, and overall survival. Researchers will track these outcomes through clinical assessments and safety monitoring. This study is designed to evaluate if careful monitoring alone is a safe alternative to anticoagulation in selected patients with isolated SSPE, potentially reducing bleeding risks from treatment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Signed informed consent
Age 18 years or older
Objective diagnosis of symptomatic or asymptomatic isolated subsegmental pulmonary embolism (SSPE)

You will not qualify if you...

Presence of leg or upper extremity deep vein thrombosis (DVT)
Active cancer treated within the last 6 months
One or more prior episodes of unprovoked venous thromboembolism
Clinical instability at presentation (low blood pressure or low oxygen levels)
Active bleeding or high risk of bleeding
Severe kidney failure (creatinine clearance less than 30 ml/min)
Severe liver insufficiency (Child-Pugh B or C)
Use of strong CYP3A4 inhibitors or inducers
Known allergy to rivaroxaban
Need for anticoagulation for other reasons
Anticoagulation treatment for more than 72 hours at screening
Hospital stay longer than 72 hours before isolated SSPE diagnosis
Known pregnancy or breastfeeding
Lack of safe contraception in women of childbearing potential
Refusal or inability to provide informed consent
Prior enrollment in this trial

Research Team

Drahomir Aujesky, Prof. MD MSc

Tobias Tritschler, Dr. MD MSc

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