Venous ThromboembolismALTERNATIVENCT03292666
Anticoagulation Length of ThErapy and Risk of New Adverse evenTs In Venous thromboEmbolism Study
An observational study of Venous Thromboembolism and Anticoagulants and Bleeding Disorders, run by University of California, San Francisco at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Anticoagulants and Bleeding Disorders
- What is being tested?
- Oral Anticoagulant
- Type of treatment
- Pill or oral medicine
- How many people
- 39,603 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2010to 21 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Incomplete information on age and sex
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente Northern California
Oakland, California, 94612
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism
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.
Read the 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.
- Being tested
- Oral Anticoagulant
- Medical subject headings
- Venous Thromboembolism, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral AnticoagulantDrug
Also called warfarin, dabigatran, rivaroxaban, apixaban, edoxaban
Oral anticoagulants used to treat or prevent venous thromboembolism
| Study group | Role | What they receive |
|---|---|---|
| Extended anticoagulation | Patients with acute VTE treated with oral anticoagulants for > 3 months Receives: Drug: Oral Anticoagulant | |
| No extended anticoagulation | Patients with acute VTE treated with oral anticoagulants for no longer than 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
All-cause death
Measured: 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
Generic health-related quality of life, measured according to the 36 item Short Form Survey
Measured: years 2018 and 2019
Anticoagulant treatment satisfaction
Anti-Clot Treatment Satisfaction Scale
Measured: years 2018 and 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Jan 2010
- Primary completion31 Dec 2019
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Margaret C. Fang, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292666
- Sponsor's protocol ID
- NOACs-1510-32651
- Acronym
- ALTERNATIVE
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2017
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism
- ClinicalTrials.gov ID
- NCT03292666
- Acronym / sponsor ID
- ALTERNATIVE / NOACs-1510-32651
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39,603 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Patient-Centered Outcomes Research Institute
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended anticoagulation | – | Drug: Oral AnticoagulantPatients with acute VTE treated with oral anticoagulants for > 3 months |
| No extended anticoagulation | – | –Patients with acute VTE treated with oral anticoagulants for no longer than 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Incomplete information on age and sex
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral AnticoagulantAlso: warfarin, dabigatran, rivaroxaban, apixaban, edoxabanOral anticoagulants used to treat or prevent venous thromboembolism | Drug | Extended anticoagulation |
Primary outcome
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
3 secondary outcomes
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)
Health-related quality of life
Time frame: years 2018 and 2019
Anticoagulant treatment satisfaction
Time frame: years 2018 and 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret C. Fang, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Anticoagulants and Bleeding Disorders, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.