Clinical observation compared to anticoagulation in low-risk patients with isolated subsegmental pulmonary embolisms: a multicenter randomized placebo-controlled study
Zusammenfassung der Studie
Pulmonary embolisms are blood clots in the pulmonary arteries and encompass a wide spectrum, ranging from large to very small (so-called subsegmental) embolisms. The vast majority of pulmonary embolisms, regardless of their size, are treated with anticoagulants, which are associated with a risk of bleeding. The risk-benefit ratio of anticoagulation in subsegmental pulmonary embolisms remains unclear to this day. This study aims to compare the prognosis of a management strategy with and without anticoagulation in patients with subsegmental pulmonary embolisms. Patients with isolated subsegmental pulmonary embolisms who have a low risk of complications are potential participants in this international study. After being informed about the study and providing appropriate consent, the presence of a thrombosis (blood clot) in the leg veins is first excluded using ultrasound. Patients with subsegmental pulmonary embolisms without simultaneous venous thrombosis are randomly assigned (randomization) to one of two groups: clinical observation plus placebo or clinical observation plus oral anticoagulant. The group allocation is double-blind, meaning that the allocation is unknown to both the patient and the physician. The two treatment groups are monitored for 90 days and compared regarding the risk of thrombosis/embolism, bleeding, mortality, quality of life, functional status, and consumption of medical resources. If it turns out that the group without anticoagulation is not inferior to the group with anticoagulation regarding these study endpoints, unnecessary treatments with anticoagulants could be avoided in the future for low-risk patients with isolated subsegmental pulmonary embolisms, thus reducing the risk of bleeding. For this study, a total of 276 patients will be randomized over a period of 4 years.
(BASEC)
Untersuchte Intervention
The vast majority of pulmonary embolisms are treated with anticoagulants regardless of their size, which is associated with an increased risk of bleeding. This study therefore investigates whether a treatment strategy without anticoagulation is not inferior to a treatment with anticoagulation concerning recurrent embolisms or thromboses in patients with very small (subsegmental) pulmonary embolisms.
(BASEC)
Untersuchte Krankheit(en)
very small, so-called subsegmental pulmonary embolisms
(BASEC)
- Age 18 years or older - Objective diagnosis of very small (so-called subsegmental) pulmonary embolisms (blood clots in the pulmonary arteries) (BASEC)
Ausschlusskriterien
- Presence of a blood clot (thrombosis) in the legs - Active cancer - Active bleeding or high risk of bleeding (BASEC)
Studienstandort
Aarau, Basel, Bern, Genf, Lausanne, Neuenburg, St Gallen, Winterthur, Zürich, Andere
(BASEC)
Aarau, Baden, Basel, Bern, Biel, Burgdorf, Frauenfeld, Genf, Lausanne, Liestal, Neuchatel, St. Gallen, Winterthur, Zürich Triemli.
(BASEC)
Sponsor
Insel Gruppe AG, Inselspital Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Drahomir Aujesky
+41 31 632 88 84
drahomirantonin.aujesky@clutterinsel.chDepartment of General Internal Medicine
(BASEC)
Allgemeine Auskünfte
Inselspital, Bern University Hospital, University of Bern,
+41 31 632 88 84
SAFE-SSPE@insel.ch(ICTRP)
Allgemeine Auskünfte
Inselspital, Bern University Hospital, University of Bern
+41 31 632 88 84
SAFE-SSPE@insel.ch(ICTRP)
Wissenschaftliche Auskünfte
Inselspital, Bern University Hospital, University of Bern,
+41 31 632 88 84
SAFE-SSPE@insel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
11.05.2020
(BASEC)
ICTRP Studien-ID
NCT04263038 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial (BASEC)
Wissenschaftlicher Titel
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial (ICTRP)
Öffentlicher Titel
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism (ICTRP)
Untersuchte Krankheit(en)
Pulmonary EmbolismEmbolismEmbolism and ThrombosisLung DiseasesCardiovascular DiseasesRespiratory Tract DiseasesVenous ThromboembolismAnticoagulant-induced BleedingBleeding (ICTRP)
Untersuchte Intervention
Drug: RivaroxabanDrug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
1. Informed Consent as documented by signature
2. Age =18 years
3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Exclusion Criteria:
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 SSP (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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Recurrent venous thromboembolism (ICTRP)
Clinically significant bleeding;All-cause mortality (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
University of Bern;Schweizerischer Nationalfonds;Leiden University Medical Center;The Ottawa Hospital;Bayer (ICTRP)
Weitere Kontakte
Drahomir Aujesky, Prof. MD MSc;Drahomir Aujesky, Prof. MD MSc, SAFE-SSPE@insel.ch, +41 31 632 88 84, Inselspital, Bern University Hospital, University of Bern, (ICTRP)
Sekundäre IDs
2019-02297 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04263038 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar