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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

Must not have

Active bleeding or at high risk of bleeding

Hospitalized for >72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 90 days of randomization

Awards & highlights

Drug Has Already Been Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with SSPE, with or without symptoms.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing bleeding or at a high risk of bleeding.

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I was in the hospital for more than 3 days before my blood clot diagnosis.

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My kidneys are not working well (very low filtration rate).

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My liver is not working well (severe issues).

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I need blood thinners for a health condition.

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I have been on blood thinners for more than 3 days.

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I have a blood clot in my leg or arm.

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My blood pressure is stable and above 100 mm Hg, and my oxygen levels are above 92% without assistance.

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I am not taking strong medications that affect liver enzyme activity.

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I have had at least one blood clot without any clear cause.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 90 days of randomization

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Recurrent venous thromboembolism

Secondary study objectives

All-cause mortality

Clinically significant bleeding

Other study objectives

Emergency departments and physician outpatient visits

Functional status

Health-related quality of life

+3 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 12Eligibility criteria met