Pulmonary Embolism (PE) Clinical Trial
Official title:
Apixaban Length-Of-Stay Pulmonary Embolism Study - Hospital Admissions (ALPHA-PE)
NCT number | NCT03595891 |
Other study ID # | CV185-640 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 20, 2017 |
Est. completion date | January 29, 2021 |
Verified date | April 2022 |
Source | Bristol-Myers Squibb |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A study based on a chart review of participants that presented with a sudden blood clot in the lung
Status | Completed |
Enrollment | 660 |
Est. completion date | January 29, 2021 |
Est. primary completion date | January 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Local Institution | Cardiff |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the average length of stay in secondary care | 60 days | ||
Secondary | Total length of stay, including repeat admissions | During the first 30 days after presentation of PE | ||
Secondary | Distribution of clinical characteristics of patients admitted with a PE | Clinical characteristics will be summarized using descriptive statistics | Baseline | |
Secondary | Distribution of demographic data of patients admitted with a PE | Demographic data will be summarized using descriptive statistics | Baseline |
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