Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial
- Conditions
- pulmonary embolism10014523venous thromboembolism
- Registration Number
- NL-OMON55205
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1) Informed Consent as documented by signature
2) Age >=18 years
3) Objective diagnosis of symptomatic or asymptomatic isolated SSPE
1) Presence of leg deep vein thrombosis (DVT) or upper extremity DVT
(subclavian vein or above)
2) Active cancer, defined as cancer treated with surgery, chemotherapy,
radiotherapy, or palliative care during the last 6 months
3) >=1 prior episode of unprovoked VTE (absence of a transient or permanent risk
factor)
4) Clinical instability (systolic blood pressure <100 mm Hg or arterial
oxygen saturation <92% at ambient air) at the time of presentation
5) Active bleeding or at high risk of bleeding
6) Severe renal failure (creatinine clearance <30ml/min)
7) Severe liver insufficiency (Child-Pugh B or C)
8) Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers
9) Known hypersensitivity to rivaroxaban
10) Need for therapeutic anticoagulation for another reason
11) Therapeutic anticoagulation for >72 hours for any reason at the time of
screening
12) Hospitalized for >72 hours prior to the diagnosis of isolated SSPE
(hospital-acquired VTE)
13) Known pregnancy or breast feeding (pregnancy test to be performed for women
of childbearing potential)
14) Lack of safe contraception in women of childbearing potential
15) Refusal or inability to provide informed consent
16) Prior enrolment in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome will be the proportion of recurrent, clinically<br /><br>symptomatic, objectively confirmed VTE within 90 days of randomization, defined<br /><br>as recurrent fatal or nonfatal PE or lower limb deep vein thrombosis (DVT;<br /><br>efficacy). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcomes will be the proportion of clinically significant<br /><br>bleeding and all-cause mortality at 90 days of randomization (safety).<br /><br>The ancillary outcomes will be health-related quality of life, functional<br /><br>status, and medical resource utilization at 90 days of randomization. In a<br /><br>post-hoc analysis, we will also assess radiological inter-observer agreement<br /><br>for SSPE</p><br>