Venous ThromboembolismNCT04736719
Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
An observational study of Venous Thromboembolism, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Apixaban and Warfarin
- How many people
- 19,002 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2020to 18 Feb 2021
- 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: This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing apixaban to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of apixaban or warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT, PE, or both.
Who may be able to join
- Either:
- Acute symptomatic proximal deep vein thrombosis (DVT) with evidence of proximal thrombosis that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with: compression ultrasound (CUS), including grey-scale or color-coded Doppler, OR - ascending contrast venography
- Acute symptomatic PE with evidence of thrombosis demonstrated by imaging as follows:
- an intraluminal filling defect in segmental or more proximal branches on spiral computed tomography (CT) scan
- an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram
- a perfusion defect of at least 75% of a segment with a local normal ventilation result (high probability) on ventilation/perfusion lung scan (VPLS)
- Men and women ages 18 years or greater
Who cannot join
- WOCBP who are unwilling or unable to use an acceptable method of birth control (such as oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, condoms, spermicides]) to avoid pregnancy for the entire study
- Women who are pregnant or breast feeding
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of venous thromboembolism (VTE)
- Active bleeding or high risk for bleeding contraindicating treatment with low-molecular weight heparin (LMWH) and a vitamin K antagonist (VKA)
- Presence of a mechanical valve
- Intracranial bleeding, intraocular bleeding, gastrointestinal bleeding 6 months prior to enrollment date
Show all 28Show fewer
- Head trauma or other major trauma 2 months prior to enrollment date
- Ischemic stroke or neurosurgery 1 week prior to enrollment date
- Any of the following one day prior to and including date of enrollment:
- Gross hematuria
- Evidence of poor healing of a major wound
- Intracranial neoplasm, arteriovenous malformation or aneurysm
- Overt major bleeding
- Documented hemorrhagic tendencies or blood dyscrasias
- Any of the following 6 months prior to or on the day of enrollment:
- Active and clinically significant liver disease
- Life expectancy < 6 months
- Bacterial endocarditis
- Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg; (subjects who have a transient, higher blood pressure elevation associated with acute PE [upper limit: systolic blood pressure 200 mm Hg or diastolic blood pressure 100 mm Hg] may enter the study;) elevated blood pressure that is persistent 1-2 days after the index DVT or PE should be treated according to local guidelines
- Platelet count <100,000/mm3
- Hemoglobin <9 g/dL
- Serum creatinine >2.5 mg/dL (221 umol/L)
- Calculated creatinine clearance <25 ml/min
- ALT or AST >2 times upper limit of normal
- Total bilirubin >1.5 times upper limit of normal (unless an alternative causative factor is identified [eg, Gilbert's syndrome])
- Heparin-induced thrombocytopenia
- Subjects requiring aspirin (ASA) >165 mg/day on day prior to or on day of enrollment
- Subjects requiring dual antiplatelet therapy (ASA plus clopidogrel or ASA plus ticlopidine) one day prior to or on enrollment. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Read the detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
- Conditions
- Venous Thromboembolism
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Apixaban dispensing claim is used as the exposure group
WarfarinDrug
Warfarin dispensing claim is used as the reference group
| Study group | Role | What they receive |
|---|---|---|
| Warfarin | Reference group Receives: Drug: Warfarin | |
| Apixaban | Exposure group Receives: Drug: Apixaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with composite of VTE and VTE-related mortality
Measured: Through study completion (a median of 74 - 96 days)
Secondary outcomes (2)
Number of patients with hospital admission for VTE
Measured: Through study completion (a median of 74 - 96 days)
Number of patients with VTE-related mortality
Measured: Through study completion ( a median of 74-96 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start22 Sep 2020
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
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 Brigham and Women's HospitalThe 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
- 19,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shirley Vichy Wang, Brigham and Women's Hospital
- Investigators
- Shirley Wang, PhD, ScM, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736719
- Sponsor's protocol ID
- 2018P002966-DUP-AMPLIFY
- Status last verified
- Jul 2023
- First submitted
- 25 Jan 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data
- ClinicalTrials.gov ID
- NCT04736719
- Acronym / sponsor ID
- 2018P002966-DUP-AMPLIFY
- Conditions
- Venous Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,002 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 3 Feb 2021 (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.
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
Detailed description
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin | – | Drug: WarfarinReference group |
| Apixaban | – | Drug: ApixabanExposure group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing apixaban to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of apixaban or warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT, PE, or both.
Key inclusion criteria (7 listed)
- Either:
- Men and women ages 18 years or greater
Key exclusion criteria (28 listed)
- WOCBP who are unwilling or unable to use an acceptable method of birth control (such as oral contraceptives, other hormonal contraceptives [vaginal products, skin patches, or implanted or injectable products], or mechanical products such as an intrauterine device or barrier methods [diaphragm, condoms, spermicides]) to avoid pregnancy for the entire study
- Women who are pregnant or breast feeding
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of venous thromboembolism (VTE)
- Active bleeding or high risk for bleeding contraindicating treatment with low-molecular weight heparin (LMWH) and a vitamin K antagonist (VKA)
- Presence of a mechanical valve
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 |
|---|---|---|
| ApixabanApixaban dispensing claim is used as the exposure group | Drug | Apixaban |
| WarfarinWarfarin dispensing claim is used as the reference group | Drug | Warfarin |
Primary outcome
Number of patients with composite of VTE and VTE-related mortality
Time frame: Through study completion (a median of 74 - 96 days)
2 secondary outcomes
Number of patients with hospital admission for VTE
Time frame: Through study completion (a median of 74 - 96 days)
Number of patients with VTE-related mortality
Time frame: Through study completion ( a median of 74-96 days)
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 27 Jul 2023.
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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.
Shirley Wang, PhD, ScM principal investigator
Brigham and Women's Hospital
1 site 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, run by Brigham and Women's Hospital at 1 site 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 7 inclusion and 28 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of patients with composite of VTE and VTE-related mortality (time frame: Through study completion (a median of 74 - 96 days)). 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 27 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.