Anticoagulation Length of ThErapy and Risk of New Adverse evenTs In Venous thromboEmbolism Study (ALTERNATIVE)
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|ClinicalTrials.gov Identifier: NCT03292666|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2017
Last Update Posted : October 5, 2020
|Condition or disease||Intervention/treatment|
|Venous Thromboembolism Anticoagulants and Bleeding Disorders||Drug: Oral Anticoagulant|
Venous thromboembolism (VTE) is a leading cause of cardiovascular death and continues to be a major public health issue in the United States. The cornerstone of current VTE treatment is anticoagulation, typically given for ≥ 3 months during the acute phase of thrombosis. Afterwards, extended-duration anticoagulation can be considered for selected higher-risk patients. Treatment options for VTE have expanded substantially in recent years, most notably through the availability of direct oral anticoagulants (DOACs). Yet there are many remaining gaps in the understanding of how to manage VTE to maximize net clinical benefit.
The long-range objective of this project is to reduce the morbidity and mortality associated with VTE in adults and evaluate contemporary treatment patterns and long-term outcomes after VTE. This initial phase of the study will assemble an observational cohort of adults with VTE diagnosed between 2010-2018. Study subjects will be identified from two integrated healthcare delivery systems (Kaiser Permanente Northern California and Kaiser Permanente Southern California) and followed until December, 2019. Data will be obtained from administrative and electronic health records, supplemented with a cross-sectional patient survey.
The first two aims will be to compare the rates of recurrent VTE and hemorrhage between (1) extended anticoagulation vs. no extended anticoagulation after VTE; and (2) DOAC vs. warfarin treatment of VTE. The third specific aim is to describe patient-defined outcomes in adults with VTE in the current treatment era. This will be accomplished by surveying subjects with VTE to collect data on generic and disease-specific quality-of-life as well as on anticoagulant treatment satisfaction. Combining clinical, outcome, and survey data with administrative data will create a contemporary cohort of VTE patients that can serve as a rich source of information for use in facilitating comparative effectiveness research addressing optimal VTE management within real-world practice settings.
|Study Type :||Observational|
|Actual Enrollment :||39603 participants|
|Official Title:||The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism|
|Actual Study Start Date :||January 1, 2010|
|Actual Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||June 21, 2022|
Patients with acute VTE treated with oral anticoagulants for > 3 months
Drug: Oral Anticoagulant
Oral anticoagulants used to treat or prevent venous thromboembolism
Other Name: warfarin, dabigatran, rivaroxaban, apixaban, edoxaban
No extended anticoagulation
Patients with acute VTE treated with oral anticoagulants for no longer than 3 months
- Recurrent venous thromboembolism [ Time Frame: From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019) ]Recurrent VTE will be defined as a new VTE encounter that is occurs after the index VTE event date. The encounter must represent a new diagnosis or symptomatology that is attributable to VTE.
- Hospitalization for hemorrhage [ Time Frame: From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019) ]Hospitalization for extracranial or intracranial hemorrhage
- Death [ Time Frame: From the index VTE date until disenrollment from the health system or the end of the planned outcome assessment (December 31, 2019) ]All-cause death
- Health-related quality of life [ Time Frame: years 2018 and 2019 ]Generic health-related quality of life, measured according to the 36 item Short Form Survey
- Anticoagulant treatment satisfaction [ Time Frame: years 2018 and 2019 ]Anti-Clot Treatment Satisfaction Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03292666
|United States, California|
|Kaiser Permanente Northern California|
|Oakland, California, United States, 94612|
|Kaiser Permanente Southern California|
|Pasadena, California, United States, 91101|
|Principal Investigator:||Margaret C. Fang, MD||University of California, San Francisco|