The Study of How Long Participants Stay in the Hospital After Receiving Apixaban for a Blood Clot in the Lung

April 29, 2022 updated by: Bristol-Myers Squibb

Apixaban Length-Of-Stay Pulmonary Embolism Study - Hospital Admissions (ALPHA-PE)

A study based on a chart review of participants that presented with a sudden blood clot in the lung

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

660

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (≥ 18 years of age) at index date presenting with acute Pulmonary Embolism (PE), which was then objectively confirmed, and received anticoagulation upon diagnosis of PE and in receipt of anticoagulation at discharge.

Description

Inclusion Criteria:

  • Adults participants at date of admission
  • Primary presentation consistent with PE followed by objectively-confirmed acute PE
  • Received anti-coagulation upon diagnosis of PE during study period and in receipt of anti-coagulation at discharge

Exclusion Criteria:

  • PE diagnosed during a hospital admission for a reason other than PE during the study period
  • Patients receiving anticoagulation at the time of presentation
  • Patients presenting outside the defined study period

Other protocol defined inclusion/exclusion criteria could apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult with acute PE before the introduction of apixaban
Other: Non-Interventional
Non-Interventional
Adult with acute PE after the introduction of apixaban
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the average length of stay in secondary care
Time Frame: 60 days
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total length of stay, including repeat admissions
Time Frame: During the first 30 days after presentation of PE
During the first 30 days after presentation of PE
Distribution of clinical characteristics of patients admitted with a PE
Time Frame: Baseline
Clinical characteristics will be summarized using descriptive statistics
Baseline
Distribution of demographic data of patients admitted with a PE
Time Frame: Baseline
Demographic data will be summarized using descriptive statistics
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2017

Primary Completion (Actual)

January 29, 2021

Study Completion (Actual)

January 29, 2021

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV185-640

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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