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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 : Completed
First Posted : September 25, 2017
Last Update Posted : November 2, 2022
Kaiser Permanente
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
The proposed research seeks to provide insights on the contemporary epidemiology, treatment, and outcomes of VTE, including examining the uptake of new treatment strategies, the efficacy and safety of different anticoagulant options, and the impact of venous thromboembolism on patient-defined outcomes, such as quality-of-life, symptom burden, and treatment satisfaction. This information is crucial to helping clinicians and patients choose between various treatment options for venous thromboembolism in order to achieve the best possible balance between the risks, benefits, and impact on health.

Condition or disease Intervention/treatment
Venous Thromboembolism Anticoagulants and Bleeding Disorders Drug: Oral Anticoagulant

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 39603 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Completion Date : June 21, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Warfarin

Group/Cohort Intervention/treatment
Extended anticoagulation
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

Primary Outcome Measures :
  1. 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.

  2. 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

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Anticoagulant treatment satisfaction [ Time Frame: years 2018 and 2019 ]
    Anti-Clot Treatment Satisfaction Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The source populations for the study will be adults diagnosed with acute venous thromboembolism who were enrolled in Kaiser Permanente Northern California or Kaiser Permanente Southern California, two large, integrated healthcare delivery systems in California.

Inclusion Criteria:

  • Adults (age ≥ 18 years) enrolled in Kaiser Permanente Northern California or Kaiser Permanente Southern California
  • Index VTE event, defined as an incident clinical encounter (inpatient, emergency department, or outpatient) with a primary or secondary diagnosis of VTE during the time period January 1, 2010 to December 31, 2018
  • Anticoagulant prescription (oral or parenteral) filled after index VTE discharge/encounter date
  • Continuous outpatient anticoagulant therapy for ≥ 3 months from fill date of prescription
  • Continuous pharmacy benefits and health plan membership for at least 12 months before the index VTE event date

Exclusion Criteria:

- Incomplete information on age and sex

Information from the National Library of Medicine

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

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United States, California
Kaiser Permanente Northern California
Oakland, California, United States, 94612
Kaiser Permanente Southern California
Pasadena, California, United States, 91101
Sponsors and Collaborators
University of California, San Francisco
Kaiser Permanente
Patient-Centered Outcomes Research Institute
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Principal Investigator: Margaret C. Fang, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03292666    
Other Study ID Numbers: NOACs-1510-32651
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Venous Thromboembolism
Hemostatic Disorders
Blood Coagulation Disorders
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action