NCT05487950|Not Yet RecruitingPhase 4DMC
Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk
SHORT RUN AF
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Sponsor study identifier
interventional
550
1 country
22
Study Start
April 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The primary objective of the Short Run AF study is to evaluate the efficacy and safety of long term anticoagulation with rivaroxaban against standard of care (SOC) in patients with ESVEA and CHA2DS2VASC score ≥3 on the incidence of ischemic stroke and peripheral embolism after 2 years follow-up and the occurrence of major bleeding events. The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis. The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2, 2022
Actual (reported)August 4, 2022
Actual (reported)April 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
incidence of first ischemic stroke or peripheral embolism
The primary efficacy endpoint is the first ischemic stroke or peripheral embolism detected clinically and on systematic cerebral MRIs in a time-to-event analysis.
during 28 months follow-up
incidence of major bleeding at any site in the body
The primary safety outcome is major bleeding at any site in the body according to the criteria of the International Society of Thrombosis and Hemostasis (ISTH)(23-25).
2-year follow-up.
the incidence of documented atrial fibrillation
2-year follow-up.
Patients in the Rivaroxaban group will receive Rivaroxaban at the dose of 15 mg once daily ((or 10 mg if renal insufficiency) during 2 years.
Patients in the control group will be followed according to the standard of care (SOC) chosen by the investigator during 2 years. Additions or changes to SOC are allowed during the patient participation in the study based on patient status and evolution (with the exception of the use of anticoagulant therapy).
Patients assigned in the Rivaroxaban group will receive 15 mg once day or 10 mg if dosage modification is needed due to renal insufficiency (Creatinine clairance calculated with the Cockroft formula between 30 or 49 ml/min).
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
RIVAROXABAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
RIVAROXABAN
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
RIVAROXABAN
Named ingredient: Rivaroxaban
View registry recordRIVAROXABAN
Named ingredient: Rivaroxaban
View registry recordFirst Submitted
August 2, 2022
First Posted
August 4, 2022
Study Start
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April 5, 2023
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 5, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 28, 2023
Record last verified: 2023-03
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Source: ClinicalTrials.gov.
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