Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration:||5 Years|
|Official Title:||Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant|
- Clot Recurrence [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
- Adherence [ Time Frame: 5 years ] [ Designated as safety issue: No ]Rivaroxaban is anticipated to be equal in adherence to warfarin given the predictability of dosing.
- Cost [ Time Frame: 5 years ] [ Designated as safety issue: No ]We will assess costs of medication and medical bills to the patients.
- Patient Satisfaction [ Time Frame: 5 years ] [ Designated as safety issue: No ]We will assess patient satisfaction with treatment.
Biospecimen Retention: Samples With DNA
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
A study group taken from existing anticoagulant clinics treated with warfarin.
A group seen in the rivaroxaban clinic under study.
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 .
A blood sample will be obtained at the initial outpatient visit within 30 days (+/- 14 days) post diagnosis and/or start of treatment and at the 180 day (+/- 14 days) follow up post treatment visit and at each annual visit for up to 5 years.
A SF 36 questionnaire will be administered at 30 days (+/- 14 days) post diagnosis and/or start of treatment and at the 180 day (+/- 14 days) follow up post treatment visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02079584
|Contact: Jeffrey A Kline, MDfirstname.lastname@example.org|
|Contact: Zachary P Kahler, MDemail@example.com|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46240|
|Contact: Jeffrey A Kline, MD|
|Principal Investigator: Jeffrey A Kline, MD|