Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism (SAFE-SSPE)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04263038 |
|
Recruitment Status :
Recruiting
First Posted : February 10, 2020
Last Update Posted : September 28, 2023
|
Sponsor:
Drahomir Aujesky
Collaborators:
University of Bern
Schweizerischer Nationalfonds
Leiden University Medical Center
The Ottawa Hospital
Bayer
Information provided by (Responsible Party):
Drahomir Aujesky, Insel Gruppe AG, University Hospital Bern
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Embolism Embolism Embolism and Thrombosis Lung Diseases Cardiovascular Diseases Respiratory Tract Diseases Venous Thromboembolism Anticoagulant-induced Bleeding Bleeding | Drug: Rivaroxaban Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 276 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial |
| Actual Study Start Date : | May 15, 2020 |
| Estimated Primary Completion Date : | February 2024 |
| Estimated Study Completion Date : | April 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pulmonary Embolism
Drug Information
available for:
Rivaroxaban
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Anticoagulation
Patients in the anticoagulation group will receive rivaroxaban 15 mg twice daily for the first 21 days, followed by 20 mg once daily for an overall treatment duration of 90 days.
|
Drug: Rivaroxaban
Anticoagulation |
|
Placebo Comparator: No anticoagulation
Patients in the group without anticoagulation will receive placebo twice daily for the first 21 days, followed by one tablet daily for an overall treatment duration of 90 days.
|
Drug: Placebo
Study drug without active agent |
Primary Outcome Measures :
- Recurrent venous thromboembolism [ Time Frame: Within 90 days of randomization ]Proportion of recurrent, clinically symptomatic, objectively confirmed venous thromboembolism (defined as recurrent fatal or nonfatal pulmonary embolism or lower limb deep vein thrombosis)
Secondary Outcome Measures :
- Clinically significant bleeding [ Time Frame: Within 90 days of randomization ]Proportion of the composite of major and clinically relevant non-major bleeding
- All-cause mortality [ Time Frame: Within 90 days of randomization ]Proportion of deaths (all causes of death will be considered)
Other Outcome Measures:
- Health-related quality of life [ Time Frame: Within 90 days of randomization ]Pulmonary embolism related quality of life as assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire
- Functional status [ Time Frame: Within 90 days of randomization ]Functional status as assessed by the post-venous thromboembolism functional status scale
- Initial length of stay (LOS) [ Time Frame: Within 90 days of randomization ]Defined as the time/date of discharge minus time/date of admission at the emergency department
- Subsequent overall hospitalizations [ Time Frame: Within 90 days of randomization ]Number of overall hospitalizations
- Emergency departments and physician outpatient visits [ Time Frame: Within 90 days of randomization ]Number of emergency department and physician outpatient visits
- Return to work or usual activities [ Time Frame: Within 90 days of randomization ]Time (days) to return to work in workers and usual activities (household) in non-workers
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed Consent as documented by signature
- Age ≥18 years
- Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263038
Contacts
| Contact: Drahomir Aujesky, Prof. MD MSc | +41 31 632 88 84 | SAFE-SSPE@insel.ch | |
| Contact: Tobias Tritschler, Dr. MD MSc | +41 31 63 2 01 46 | SAFE-SSPE@insel.ch |
Locations
Show 30 study locations
Sponsors and Collaborators
Drahomir Aujesky
University of Bern
Schweizerischer Nationalfonds
Leiden University Medical Center
The Ottawa Hospital
Bayer
Investigators
| Study Director: | Drahomir Aujesky, Prof. MD MSc | Inselspital, Bern University Hospital, University of Bern |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Drahomir Aujesky, Prof. Dr., MD, MSc, Insel Gruppe AG, University Hospital Bern |
| ClinicalTrials.gov Identifier: | NCT04263038 |
| Other Study ID Numbers: |
2019-02297 |
| First Posted: | February 10, 2020 Key Record Dates |
| Last Update Posted: | September 28, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | After publication of the study results, a de-identified patient-level data set relating to the primary publication along with the latest version of the study protocol, the informed consent form, the statistical analysis plan, the code used for the analyses, and the Data Management and Quality Plan describing all data management aspects of the study will be made publicly available for replication of the study results and secondary data analyses in the Bern Open Repository and Information System (BORIS) Research Data, an online non-commercial data repository that meets Swiss National Science Foundation requirements for FAIR Data Principles (www.force11.org/group/fairgroup/fairprinciples) |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code |
| Time Frame: | After publication of the study results |
| Access Criteria: | Data will be publicly available for replication of the study results and secondary data analyses in the Bern Open Repository and Information System (BORIS) Research Data |
| URL: | https://www.boris.unibe.ch/ |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Drahomir Aujesky, Insel Gruppe AG, University Hospital Bern:
|
subsegmental pulmonary embolism |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Cardiovascular Diseases Thrombosis Embolism Thromboembolism Venous Thromboembolism Embolism and Thrombosis Hemorrhage |
Pathologic Processes Vascular Diseases Rivaroxaban Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |