- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893591
A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity
March 31, 2020 updated by: Lee Goldstein, HaEmek Medical Center, Israel
A Prospective Cohort Study to Examine the Need to Adjust the Dose of Anticoagulant Apixaban When Used in Patients With Atrial Fibrillation and Obesity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
82
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Afula, Israel, 18101
- HaEmek Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
adults
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Anasarca
- acute renal failure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Body mass index below 35
|
one Blood sample
|
Body mass index 35 and above
|
one Blood sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban.
Time Frame: 6 month
|
6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2019
Primary Completion (Actual)
February 29, 2020
Study Completion (Actual)
February 29, 2020
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
March 26, 2019
First Posted (Actual)
March 28, 2019
Study Record Updates
Last Update Posted (Actual)
April 1, 2020
Last Update Submitted That Met QC Criteria
March 31, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Arrhythmias, Cardiac
- Obesity
- Atrial Fibrillation
- Molecular Mechanisms of Pharmacological Action
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Anticoagulants
- Heparin, Low-Molecular-Weight
- Dalteparin
Other Study ID Numbers
- 0004-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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