Pulmonary Embolism (PE)NCT03595891
The Study of How Long Participants Stay in the Hospital After Receiving Apixaban for a Blood Clot in the Lung
An observational study of Pulmonary Embolism (PE) and Pulmonary Thromboembolism, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
A study based on a chart review of participants that presented with a sudden blood clot in the lung Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (PE), Pulmonary Thromboembolism
- What is being tested?
- Non-Interventional
- How many people
- 660 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2017to 29 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Pulmonary Embolism (PE), Pulmonary Thromboembolism
- Being tested
- Non-Interventional
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
| Study group | Role | What they receive |
|---|---|---|
| Adult with acute PE before the introduction of apixaban | Not described Receives: Other: Non-Interventional | |
| Adult with acute PE after the introduction of apixaban | Not described Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the average length of stay in secondary care
Measured: 60 days
Secondary outcomes (3)
Total length of stay, including repeat admissions
Measured: During the first 30 days after presentation of PE
Distribution of clinical characteristics of patients admitted with a PE
Clinical characteristics will be summarized using descriptive statistics
Measured: Baseline
Distribution of demographic data of patients admitted with a PE
Demographic data will be summarized using descriptive statistics
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start20 Jan 2017
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism (PE)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595891
- Sponsor's protocol ID
- CV185-640
- Status last verified
- Apr 2022
- First submitted
- 8 May 2018
- Last updated
- 5 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Length-Of-Stay Pulmonary Embolism Study - Hospital Admissions (ALPHA-PE)
- ClinicalTrials.gov ID
- NCT03595891
- Acronym / sponsor ID
- CV185-640
- Conditions
- Pulmonary Embolism (PE), Pulmonary Thromboembolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 23 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study based on a chart review of participants that presented with a sudden blood clot in the lung
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult with acute PE before the introduction of apixaban | – | Other: Non-Interventional |
| Adult with acute PE after the introduction of apixaban | – | Other: Non-Interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | Adult with acute PE after the introduction of apixaban, Adult with acute PE before the introduction of apixaban |
Primary outcome
Compare the average length of stay in secondary care
Time frame: 60 days
3 secondary outcomes
Total length of stay, including repeat admissions
Time frame: During the first 30 days after presentation of PE
Distribution of clinical characteristics of patients admitted with a PE
Time frame: Baseline
Distribution of demographic data of patients admitted with a PE
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism (PE) and Pulmonary Thromboembolism, run by Bristol-Myers Squibb at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the average length of stay in secondary care (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.