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Study on Monitoring vs. Rivaroxaban for Patients with Low-Risk Isolated Subsegmental Pulmonary Embolism

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Isolated Subsegmental Pulmonary Embolism (SSPE), which is a type of blood clot that occurs in the lungs. The trial aims to evaluate the effectiveness and safety of two different approaches for managing this condition in patients who are considered low-risk. One approach involves close monitoring, known as clinical surveillance, without the use of blood-thinning medication. The other approach uses a medication called Rivaroxaban, which is a type of anticoagulant or blood thinner, to prevent further clotting. The medication is provided in the form of a film-coated tablet and is taken orally.

The purpose of the study is to compare these two approaches to see which is more effective in preventing further blood clots and ensuring patient safety. Participants in the study will be randomly assigned to either receive clinical surveillance or the anticoagulant treatment with Rivaroxaban. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last for a period of up to 90 days, during which time participants will be monitored for any symptoms of recurrent blood clots, as well as any significant bleeding or other health issues.

Throughout the study, researchers will also assess the overall health and quality of life of the participants, as well as their use of medical resources. The goal is to determine whether clinical surveillance alone is as effective and safe as using anticoagulation therapy with Rivaroxaban for managing low-risk patients with isolated SSPE. This information will help guide future treatment decisions for this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after providing informed consent, which is documented by a signature.
Eligibility requires being at least 18 years old and having an objective diagnosis of isolated subsegmental pulmonary embolism (SSPE).
Step 2
Randomization
Participants are randomly assigned to one of two groups: clinical surveillance or anticoagulation treatment.
The purpose is to compare the frequency of symptomatic, recurrent venous thromboembolism (VTE) between the two groups.
Step 3
Treatment phase
If assigned to the anticoagulation group, the medication used is Rivaroxaban Bayer, administered orally as a film-coated tablet.
The dosage and frequency of administration are determined by the study protocol and medical team.
Step 4
Monitoring and follow-up
Participants are monitored for 90 days to assess the primary outcome, which is the proportion of recurrent, clinically symptomatic, objectively confirmed VTE.
Secondary outcomes include the proportion of clinically significant bleeding and all-cause mortality, as well as health-related quality of life, functional status, and medical resource utilization.
Step 5
Completion of the study
The study is estimated to conclude by May 31, 2026.
Upon completion, data collected will contribute to understanding the efficacy and safety of clinical surveillance versus anticoagulation in low-risk patients with isolated SSPE.

Who can join the trial?

4 criteria

Provide Informed Consent, which means you agree to participate in the study by signing a document.
Be at least 18 years old.
Have a confirmed diagnosis of Isolated Subsegmental Pulmonary Embolism (SSPE), which is a condition where a small blood clot is found in the lungs. This can be with or without symptoms.
Be part of the general health insurance system, but this is only necessary if the study is conducted in France.

Who cannot join the trial?

10 criteria

Patients who are not considered low-risk for the condition being studied.
Patients who have other medical conditions that could interfere with the study.
Patients who are unable to follow the study procedures or attend follow-up visits.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients who have a history of severe allergic reactions to any of the study medications.
Patients who have a condition that requires them to take blood thinners, which are medications that help prevent blood clots.
Patients who have had a recent major surgery or trauma.
Patients who have a life expectancy of less than 6 months.
Patients who have a history of substance abuse or mental health conditions that could affect their ability to participate in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Albert Schweitzer Ziekenhuis
Verified
Dordrecht, The Netherlands
Cliniques Universitaires Saint-Luc
Responsive
Woluwe-Saint-Lambert, Belgium
Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands

Trial locations

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Investigated drugs

Anticoagulation Therapy
This therapy involves using medications that help prevent blood clots from forming or growing larger. In this trial, anticoagulation is used to treat patients with isolated subsegmental pulmonary embolism (SSPE) to see if it can reduce the risk of recurrent venous thromboembolism (VTE). These medications work by thinning the blood, which can help prevent complications related to blood clots.
Clinical Surveillance
This approach involves closely monitoring patients without giving them anticoagulation medications. The goal is to observe the patients' health and detect any changes or symptoms that might indicate a recurrence of venous thromboembolism (VTE). This method is being tested to see if it is as effective and safe as using anticoagulation therapy for low-risk patients with isolated subsegmental pulmonary embolism (SSPE).

Rivaroxaban

What is already known about the treatment

Anticoagulant Medication – This medication is typically administered orally or via injection, depending on the specific drug formulation. It is currently well-established in medical practice and literature for preventing and treating blood clots. The main therapeutic indication for this medication is to prevent recurrent venous thromboembolism, including conditions like isolated subsegmental pulmonary embolism. At the molecular level, anticoagulants work by inhibiting specific factors in the blood clotting process, thereby reducing the formation of clots. They are classified pharmacologically as anticoagulants, which are a group of drugs that help prevent the coagulation of blood.

Investigated diseases

Isolated Subsegmental Pulmonary Embolism – This condition occurs when a small blood clot blocks one of the smaller branches of the pulmonary artery in the lungs. It is a type of pulmonary embolism that affects only a subsegment of the lung, meaning it is more localized than other forms. The condition can develop suddenly and may cause symptoms such as shortness of breath, chest pain, or a rapid heartbeat. It is often discovered incidentally during imaging tests for other conditions. The progression of the disease can vary, with some individuals experiencing no symptoms while others may have more noticeable effects. Monitoring and management are typically required to prevent potential complications.