NCT04736420

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78,605

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2021

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

January 25, 2021

Last Update Submit

July 25, 2023

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Relative hazard of venous thromboembolism

    Claims-based algorithm: see attached protocol for full definition

    Through study completion or point of censoring, up to 12 months

Secondary Outcomes (1)

  • Relative hazard of a major bleeding event

    Through study completion or point of censoring, up to 12 months

Study Arms (2)

Warfarin

Reference group

Drug: Warfarin

Rivaroxaban

Exposure group

Drug: Rivaroxaban

Interventions

RivaroxabanDRUG

Rivaroxaban dispensing claim is used as the exposure group

Rivaroxaban
WarfarinDRUG

Warfarin dispensing claim is used as the reference group

Warfarin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT without symptomatic PE.

You may qualify if:

  • \- Confirmed acute symptomatic proximal DVT without symptomatic PE

You may not qualify if:

  • Age ≤ 18
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT or PE two weeks prior to and including day of enrollment
  • Other indications for VKA than DVT and/or PE six months prior to and including day of enrollment
  • Any of the following six months prior to and including day of enrollment:
  • Creatine clearance \< 30 ml/min
  • Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT\>3 ULN
  • Bacterial endocarditis
  • Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA
  • Systolic blood pressure \> 180 mgHg or diastolic blood pressure \> 110 mgHg
  • Childbearing potential without proper contraceptive measures, pregnancy, or breastfeeding
  • Life expectancy \< 3 months in the last year prior to and including day of enrollment
  • Concomitant use of strong CYP3A4 inhibitors (e.g. HIV protease inhibitors, systemic ketoconazole) or strong CYP3A4 inducers two weeks prior to and including day of enrollment
  • Symptomatic pulmonary embolism two weeks prior to and including day of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

RivaroxabanWarfarin

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsMorpholinesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic 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
Assistant Professor

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 28, 2023

Record last verified: 2023-07

Locations

US(1)