Replication of the RECOVER-II Anticoagulant Trial in Healthcare Claims Data

NCT04735523 | Completed FDA Drug

• 1 other identifier: 2018P002966-DUP-RE-COVER II
• Study Type: observational
• Target: 5,350
• 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)

• VTE and cause-specific mortality

  Through study completion (a median of 84-89 days)

Secondary Outcomes (2)

• Hospital admission for VTE

  Through study completion (a median of 84-89 days)

• Cause-specific mortality

  Through study completion (a median of 84-89 days)

Study Arms (2)

Warfarin

Reference group

Drug: Warfarin

Dabigatran

Exposure group

Drug: Dabigatran

Interventions

Dabigatran DRUG

Dabigatran dispensing claim is used as the exposure group

Dabigatran

Warfarin DRUG

Warfarin dispensing claim is used as the reference group

Warfarin

Eligibility Criteria

• Age: 18 Years - 120 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 dabigatran to warfarin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of dabigatran to warfarin (index date). We will restrict the analyses to patients with a diagnosis of proximal DVT or PE.

You may qualify if:

• Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate.
• Men and women ages 18 years or greater

You may not qualify if:

• PE satisfying at least one of the following criteria:
• Haemodynamic instability
• OR Embolectomy is indicated or performed
• OR thrombolytic therapy is indicated or performed
• OR suspected source of PE is other than blood clots from the legs
• Actual or anticipated use of vena cava filter
• Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
• Known anaemia
• Need of anticoagulant treatment for disorders other than VTE
• Recent unstable cardiovascular disease
• Elevated AST or ALT \> 3x ULN
• Liver disease expected to have any potential impact on survival (severe liver conditions)
• Severe renal impairment
• Contraindications to anticoagulant therapy (not specified)
• Recent or active major bleeding

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

Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

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: August 1, 2023

Record last verified: 2023-07

Locations

US (1)