A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity
A Prospective Cohort Study to Examine the Need to Adjust the Dose of Anticoagulant Apixaban When Used in Patients With Atrial Fibrillation and Obesity
1 other identifier
observational
82
1 country
1
Brief Summary
A prospective cohort study to determine whether a high body weight (BMI equal to or greater than 35 kg / m 2) has an effect on anticoagulant Apixaban level in the blood of patients with atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2019
CompletedFirst Posted
Study publicly available on registry
March 28, 2019
CompletedStudy Start
First participant enrolled
May 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 29, 2020
CompletedApril 1, 2020
March 1, 2020
10 months
March 26, 2019
March 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban.
6 month
Study Arms (2)
Body mass index below 35
Body mass index 35 and above
Interventions
Eligibility Criteria
adults
You may qualify if:
- \- hospitalized Patients on Steady State level of Apixaban, based on the data given in the hospital ward . A level of Steady State is received within two days of treatment.
You may not qualify if:
- Anasarca
- acute renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
HaEmek Medical Center
Afula, 18101, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2019
First Posted
March 28, 2019
Study Start
May 6, 2019
Primary Completion
February 29, 2020
Study Completion
February 29, 2020
Last Updated
April 1, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share