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New treatment option for Pulmonary Embolism
Official title Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism
ClinicalTrials.gov ID: NCT04263038
What this study is testing
What is Rivaroxaban?
Rivaroxaban is an investigational medicine, being studied as a potential treatment for pulmonary embolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Informed Consent as documented by signature
- Age ≥18 years
- Objective diagnosis of symptomatic or asymptomatic isolated SSPE
You likely can't join if
- Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
- Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
- ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
- Clinical instability (systolic blood pressure \<100 mm Hg or arterial Oxygen saturation \<92% at ambient air) at the time of presentation
- Active bleeding or at high risk of bleeding
- Severe renal failure (creatinine clearance \<30ml/min)
See the full eligibility criteria
- Informed Consent as documented by signature
- Age ≥18 years
- Objective diagnosis of symptomatic or asymptomatic isolated SSPE
- Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)
- Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months
- ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)
- Clinical instability (systolic blood pressure \<100 mm Hg or arterial Oxygen saturation \<92% at ambient air) at the time of presentation
- Active bleeding or at high risk of bleeding
- Severe renal failure (creatinine clearance \<30ml/min)
- Severe liver insufficiency (Child-Pugh B or C)
- Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
- Known hypersensitivity to rivaroxaban
- Need for therapeutic anticoagulation for another reason
- Therapeutic anticoagulation for \>72 hours for any reason at the time of screening
- Hospitalized for \>72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)
- Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)
- Lack of safe contraception in women of childbearing potential
- Refusal or inability to provide informed consent
- Prior enrolment in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Woluwe-Saint-Lambert, Brussels Capital, Belgium
- Liège, Belgium
- Ottawa, Canada
- Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France
- Brest, France
- Clermont-Ferrand, France
- Dijon, France
- Lyon, France
- Marseille, France
- Rouen, France
- Saint-Priest-en-Jarez, France
- Dordrecht, Netherlands
- Enschede, Netherlands
- Leiden, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Zwolle, Netherlands
- Liestal, Basel, Switzerland
- Aarau, Canton of Aargau, Switzerland
- Bern, Canton of Bern, Switzerland
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Woluwe-Saint-Lambert, Brussels Capital, Belgium; Liège, Belgium; Ottawa, Canada; Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, France; Brest, France; Clermont-Ferrand, France and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.