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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03595891
Recruitment Status : Unknown
Verified December 2018 by Bristol-Myers Squibb.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
A study based on a chart review of participants that presented with a sudden blood clot in the lung

Condition or disease Intervention/treatment
Pulmonary Embolism (PE) Pulmonary Thromboembolism Other: Non-Interventional

Study Design
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Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Apixaban Length-Of-Stay Pulmonary Embolism Study - Hospital Admissions (ALPHA-PE)
Actual Study Start Date : January 20, 2017
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Compare the average length of stay in secondary care [ Time Frame: 60 days ]

Secondary Outcome Measures :
  1. Total length of stay, including repeat admissions [ Time Frame: During the first 30 days after presentation of PE ]
  2. Distribution of clinical characteristics of patients admitted with a PE [ Time Frame: Baseline ]
    Clinical characteristics will be summarized using descriptive statistics

  3. Distribution of demographic data of patients admitted with a PE [ Time Frame: Baseline ]
    Demographic data will be summarized using descriptive statistics


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595891


Locations
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United Kingdom
Local Institution
Cardiff, United Kingdom, CF23 8RS
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03595891    
Other Study ID Numbers: CV185-640
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Thromboembolism
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases