Indiana University
Indianapolis, Indiana, 46240, United States
NCT Number: NCT02079584
The objectives of this registry are to measure the outcomes, cost, adherence pattern and experience of patients treated as outpatients with rivaroxaban after being diagnosed with blood clots in the emergency department. The investigators hypothesize that patients will have a relatively low rate of adverse events and higher adherence than has been reported historically for warfarin treatment. Patients will be scheduled for follow up care with one of Dr. Kline's Outpatient Thrombosis clinics at Methodist Hospital, Eskenazi Health Services and the Baylor University Medical Center (Dallas, TX) after diagnosis and treatment of pulmonary embolism (PE) or deep vein thrombosis (DVT).
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Observational
Indianapolis, Indiana, 46240, United States
Information will be obtained from the patient medical records, past medical history, physical examination at initial outpatient clinic visit 30 days (+/- 14 days) and 6 months or 180 days (+/- 14 days) post diagnosis or start of treatment, then annual follow ups for up to 5 years. The data will be collected and stored in a database, the IU RedCap database system will be used to develop a database and store information .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
Time frame: 5 years
The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
Time frame: 5 years
Bleeding that requires change in therapy
Time frame: 5 years
Number of patients discontinuing anticoagulation in first 30 days and reason why
Indiana University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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