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Anticoagulant

Surveillance vs. Rivaroxaban for Pulmonary Embolism (SAFE-SSPE Trial)

Phase 4
Recruiting
Research Sponsored by Drahomir Aujesky
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Objective diagnosis of symptomatic or asymptomatic isolated SSPE
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 90 days of randomization
Awards & highlights

SAFE-SSPE Trial Summary

This trial is testing whether it's safe to withhold anticoagulation treatment in low-risk patients with isolated subsegmental pulmonary embolism.

Who is the study for?
This trial is for adults over 18 with a confirmed diagnosis of isolated subsegmental pulmonary embolism (SSPE), which are small blood clots in the lungs. It's not for those with active cancer, pregnant or breastfeeding women, people at high risk of bleeding, severe kidney or liver issues, or anyone on certain drugs that affect rivaroxaban.Check my eligibility
What is being tested?
The study compares clinical surveillance without anticoagulation to treatment with Rivaroxaban in low-risk patients with SSPE. The goal is to see if monitoring alone is as safe and effective as using the medication to prevent further clotting.See study design
What are the potential side effects?
Rivaroxaban can cause bleeding complications including serious internal bleeds. Other side effects may include pain in limbs, muscle spasm, itching, blisters and other less common symptoms like fainting or allergic reactions.

SAFE-SSPE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with SSPE, with or without symptoms.
Select...
I am 18 years old or older.

SAFE-SSPE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 90 days of randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 90 days of randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrent venous thromboembolism
Secondary outcome measures
All-cause mortality
Clinically significant bleeding
Other outcome measures
Emergency departments and physician outpatient visits
Functional status
Health-related quality of life
+3 more

SAFE-SSPE Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: AnticoagulationActive Control1 Intervention
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.
Group II: No anticoagulationPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Drahomir AujeskyLead Sponsor
University of BernOTHER
347 Previous Clinical Trials
1,381,138 Total Patients Enrolled
3 Trials studying Pulmonary Embolism
2,413 Patients Enrolled for Pulmonary Embolism
Schweizerischer NationalfondsOTHER
6 Previous Clinical Trials
2,652 Total Patients Enrolled

Media Library

Rivaroxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04263038 — Phase 4
Rivaroxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04263038 — Phase 4
Pulmonary Embolism Research Study Groups: Anticoagulation, No anticoagulation
Pulmonary Embolism Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT04263038 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research set a precedent for similar studies?

"Anticoagulation has been under the microscope since 2015, when Bayer Healthcare Pharmaceuticals first sponsored its Phase 1 trial. In 2018, this drug received official approval in phase 3 and is now being tested across 37 nations with 58 live trials currently running in 351 cities."

Answered by AI

To what ailments is anticoagulation typically prescribed?

"Anticoagulation is a commonly used form of treatment for venous thromboembolism and other ailments such as deep vein thrombosis, chronic coronary artery disease, and cerebrovascular accident."

Answered by AI

Is there currently an opportunity to sign up for the research protocol?

"Indeed, the data on clinicaltrials.gov illustrates that this medical trial is accepting participants. It was first posted in May 2020 and was recently updated in June 2022 with 276 patients being sought from a single location."

Answered by AI

Has the Food and Drug Administration authorized Anticoagulation for public use?

"As this treatment is approved, the safety of anticoagulation was rated a 3. This score takes into account that this is Phase 4 trial."

Answered by AI

What is the existing cohort size for this research?

"Affirmative. Data hosted on clinicaltrials.gov states that this experiment, which was originally posted on May 15th 2020, is still open for recruitment. The research team needs to acquire 276 individuals from 1 medical facility to complete their study."

Answered by AI
~57 spots leftby Mar 2025