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Massive study tests if insurance records can mimic Gold-Standard drug trials

NCT ID NCT04736420

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study looks at healthcare claims from over 78,000 people to see if it can reproduce the results of the EINSTEIN-DVT trial, which compared two blood thinners (rivaroxaban and warfarin) for treating blood clots. The goal is not to test a new drug, but to learn whether real-world data can reliably mimic clinical trials. If it works, this approach could help researchers answer questions faster and cheaper using existing health records.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rivaroxaban and Warfarin
What this could lead to
If successful, this could show that analyzing healthcare claims data can reliably reproduce clinical trial results, potentially speeding up future research.
What could go wrong
This is an observational study using existing data, not a new treatment trial. Results may not perfectly match the original trial due to data limitations or unmeasured factors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

78,605 people

The number who actually took part.

Started

Sep 2020

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Criteria: Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Inclusion Criteria: \- Confirmed acute symptomatic proximal DVT without symptomatic PE Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

venous thromboembolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Venous thromboembolism

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.