NCT03595891

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 23, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

4 years

First QC Date

May 8, 2018

Last Update Submit

April 29, 2022

Conditions

Pulmonary Embolism (PE)Pulmonary Thromboembolism

Outcome Measures

Primary Outcomes (1)

  • Compare the average length of stay in secondary care

    60 days

Secondary Outcomes (3)

  • Total length of stay, including repeat admissions

    During the first 30 days after presentation of PE

  • Distribution of clinical characteristics of patients admitted with a PE

    Baseline

  • Distribution of demographic data of patients admitted with a PE

    Baseline

Study Arms (2)

Adult with acute PE before the introduction of apixaban

Other: Non-Interventional

Adult with acute PE after the introduction of apixaban

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Adult with acute PE after the introduction of apixabanAdult with acute PE before the introduction of apixaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Cardiff, CF23 8RS, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2018

First Posted

July 23, 2018

Study Start

January 20, 2017

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

May 5, 2022

Record last verified: 2022-04

Locations

GB(1)