Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant
|ClinicalTrials.gov Identifier: NCT02079584|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2014
Last Update Posted : March 16, 2017
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||350 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Outpatient Treatment of Low-Risk Venous Thromboembolism With Target Specific Anticoagulant|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
A study group taken from existing anticoagulant clinics treated with warfarin.
A group seen in the rivaroxaban clinic under study.
- Clot Recurrence [ Time Frame: 5 years ]The primary outcome is clot recurrence, with the rivaroxaban cohort expected to be equivalent or improved with warfarin.
- Adherence [ Time Frame: 5 years ]Rivaroxaban is anticipated to be equal in adherence to warfarin given the predictability of dosing.
- Cost [ Time Frame: 5 years ]We will assess costs of medication and medical bills to the patients.
- Patient Satisfaction [ Time Frame: 5 years ]We will assess patient satisfaction with treatment.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079584
|United States, Indiana|
|Indianapolis, Indiana, United States, 46240|