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Surveillance vs. Rivaroxaban for Pulmonary Embolism (SAFE-SSPE Trial)
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.
SAFE-SSPE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAFE-SSPE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SAFE-SSPE Trial Design
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Who is running the clinical trial?
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- I am currently experiencing bleeding or at a high risk of bleeding.My kidneys are not working well (very low filtration rate).My liver is not working well (severe issues).I was in the hospital for more than 3 days before my blood clot diagnosis.I need blood thinners for a health condition.You are allergic to rivaroxaban.I have been on blood thinners for more than 3 days.I have been diagnosed with SSPE, with or without symptoms.I have a blood clot in my leg or arm.My blood pressure is stable and above 100 mm Hg, and my oxygen levels are above 92% without assistance.I am not taking strong medications that affect liver enzyme activity.I am 18 years old or older.I have been treated for cancer in the last 6 months.I have had at least one blood clot without any clear cause.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- Group 1: Anticoagulation
- Group 2: No anticoagulation
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Frequently Asked Questions
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."
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."
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."
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."
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."
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