Anticoagulation Length of ThErapy and Risk of New Adverse evenTs In Venous thromboEmbolism Study

NCT03292666 | Completed FDA Drug

• 1 other identifier: NOACs-1510-32651
• Study Type: observational
• Target: 39,603
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Thromboembolism; Anticoagulants and Bleeding Disorders

Outcome Measures

Primary Outcomes (2)

• Recurrent venous thromboembolism

  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.

  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 hemorrhage

  Hospitalization for extracranial or intracranial hemorrhage

  From the index VTE date until death, disenrollment from the health system, or the end of the planned outcome assessment (December 31, 2019)

Secondary Outcomes (3)

• Death

  From the index VTE date until disenrollment from the health system or the end of the planned outcome assessment (December 31, 2019)

• Health-related quality of life

  years 2018 and 2019

• Anticoagulant treatment satisfaction

  years 2018 and 2019

Study Arms (2)

Extended anticoagulation

Patients with acute VTE treated with oral anticoagulants for \> 3 months

Drug: Oral Anticoagulant

No extended anticoagulation

Patients with acute VTE treated with oral anticoagulants for no longer than 3 months

Interventions

Oral Anticoagulant DRUG

Oral anticoagulants used to treat or prevent venous thromboembolism

Also known as: warfarin, dabigatran, rivaroxaban, apixaban, edoxaban

Extended anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Incomplete information on age and sex

Sponsors & Collaborators

• University of California, San Francisco: lead
• Kaiser Permanente: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (2)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism; Hemostatic Disorders

Interventions

Anticoagulants; Warfarin; Dabigatran; Rivaroxaban; apixaban; edoxaban

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Margaret C. Fang, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 25, 2017
• Study Start: January 1, 2010
• Primary Completion: December 31, 2019
• Study Completion: June 21, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)