BridgeMD
Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
EU CTIS ID: 2023-507801-32-00
What this study is testing
The overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE. Objective 1: To compare the frequency of symptomatic, recurrent venous thromboembolism (VTE) in low-risk patients with isolated SSPE randomized to receive clinical surveillance or anticoagulation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed Consent as documented by signature
- Age ≥18 years
- Objective diagnosis of symptomatic or asymptomatic isolated SSPE
- Affiliation to the general health insurance regime (only for study sites in France)
You likely can't join if
- Presence of leg DVT or upper extremity DVT (subclavian vein or above)
- 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 SSPE (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
See the full eligibility criteria
- Informed Consent as documented by signature
- Age ≥18 years
- Objective diagnosis of symptomatic or asymptomatic isolated SSPE
- Affiliation to the general health insurance regime (only for study sites in France)
- Presence of leg DVT or upper extremity DVT (subclavian vein or above)
- 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 SSPE (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 (specification for study sites in France: guardianship, conservatorship, judicial protection or unprotected person with a cognitive impairment that does not allow sufficient understanding of the study procedures)
- Prior enrolment in this trial
- Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months; or presence of metastatic cancer
- ≥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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Switzerland
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Switzerland. 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 EU CTIS; the study team decides eligibility.