A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity
Sponsor
HaEmek Medical Center, Israel (Other)
Overall Status
Completed
CT.gov ID
NCT03893591
Collaborator
(none)
82
1
9.8
8.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
82 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Cohort Study to Examine the Need to Adjust the Dose of Anticoagulant Apixaban When Used in Patients With Atrial Fibrillation and Obesity
Actual Study Start Date
:
May 6, 2019
Actual Primary Completion Date
:
Feb 29, 2020
Actual Study Completion Date
:
Feb 29, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Body mass index below 35
|
Diagnostic Test: Anti Xa levels
one Blood sample
|
| Body mass index 35 and above
|
Diagnostic Test: Anti Xa levels
one Blood sample
|
Outcome Measures
Primary Outcome Measures
- Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban. [6 month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HaEmek Medical Center | Afula | Israel | 18101 |
Sponsors and Collaborators
- HaEmek Medical Center, Israel
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lee Goldstein,
Principal Investigator,
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT03893591
Other Study ID Numbers:
- 0004-19
First Posted:
Mar 28, 2019
Last Update Posted:
Apr 1, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: