Replication of the AMPLIFY Anticoagulant Trial in Healthcare Claims Data

NCT04736719 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-AMPLIFY
• Study Type: observational
• Target: 19,002
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

• Number of patients with composite of VTE and VTE-related mortality

  Through study completion (a median of 74 - 96 days)

Secondary Outcomes (2)

• Number of patients with hospital admission for VTE

  Through study completion (a median of 74 - 96 days)

• Number of patients with VTE-related mortality

  Through study completion ( a median of 74-96 days)

Study Arms (2)

Warfarin

Reference group

Drug: Warfarin

Apixaban

Exposure group

Drug: Apixaban

Interventions

Apixaban DRUG

Apixaban dispensing claim is used as the exposure group

Apixaban

Warfarin DRUG

Warfarin dispensing claim is used as the reference group

Warfarin

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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:

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

apixaban; Warfarin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shirley Wang, PhD, ScM

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 3, 2021
• Study Start: September 22, 2020
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

US (1)