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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04735523
• Other study ID #: 2018P002966-DUP-RE-COVER II
• Status: Completed
• Start date: September 22, 2020
• Est. completion date: February 18, 2021

Study information

• Verified date: July 2023
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5350
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions.

Eligible cohort entry dates:

Market availability of dabigatran in the U.S. for treatment of deep vein thrombosis and pulmonary embolism started on April 7, 2014

• For Medicare: April 7, 2014 - December 31, 2017 (end of available data)

• For Marketscan: April 7, 2014 - December 31, 2018 (end of available data)

• For Optum: April 7, 2014 - March 31, 2020 (end of available data)

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Recent brain, eye, or spinal cord injury or surgery

• Malignant or severe, uncontrolled hypertension

• Active infective endocarditis

• Mechanical prosthetic heart valve (recently implanted - RE-ALIGN trial)

• Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception

• Patients who have developed transaminase elevations upon exposure to ximelagatran

• Patients considered unsuitable for inclusion by the investigator

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Dabigatran
Dabigatran dispensing claim is used as the exposure group
• Warfarin
Warfarin dispensing claim is used as the reference group

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE and cause-specific mortality		Through study completion (a median of 84-89 days)
Secondary	Hospital admission for VTE		Through study completion (a median of 84-89 days)
Secondary	Cause-specific mortality		Through study completion (a median of 84-89 days)