AnticoagulantNCT03893591
A Prospective Study to Examine the Need to Adjust the Dose of Apixaban When Used in Atrial Fibrillation and Obesity
An observational study of Anticoagulant and Apixaban, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant, Apixaban, Obesity
- What is being tested?
- Anti Xa levels
- How many people
- 82 participants
- Where
- 1 siteIsrael
- Study dates
- 6 May 2019to 29 Feb 2020
- 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
- Adult, Older adult
Study population: adults
Who may be able to join
- 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.
Who cannot join
- Anasarca
- acute renal failure
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Anticoagulant, Apixaban, Obesity
- Being tested
- Anti Xa levels
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Xa levelsDiagnostic test
one Blood sample
| Study group | Role | What they receive |
|---|---|---|
| Body mass index below 35 | Not described Receives: Diagnostic Test: Anti Xa levels | |
| Body mass index 35 and above | Not described Receives: Diagnostic Test: Anti Xa levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start6 May 2019
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Goldstein, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893591
- Sponsor's protocol ID
- 0004-19
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2019
- Last updated
- 1 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03893591
- Acronym / sponsor ID
- 0004-19
- Conditions
- Anticoagulant, Apixaban, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 6 May 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 28 Mar 2019 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body mass index below 35 | – | Diagnostic Test: Anti Xa levels |
| Body mass index 35 and above | – | Diagnostic Test: Anti Xa levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adults
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Anasarca
- acute renal failure
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 |
|---|---|---|
| Anti Xa levelsone Blood sample | Diagnostic test | Body mass index 35 and above, Body mass index below 35 |
Primary outcome
Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban.
Time frame: 6 month
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 1 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Anticoagulant
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Not yet recruitingObservational study
High-risk Antithrombotic Drugs at Discharge and Consultation for Hemorrhagic or Thromboembolic Events in the Emergency Department
Acute Disease
RecruitingPhase 3
Testing a New Treatment Strategy to Improve Secondary Stroke Prevention for Older Adults: The STROKE75+ Trial
Stroke, Ischemic
Not yet recruitingObservational study
Changes in the Etiology of Acute Limb Ischemia in the DOAK Era
Acute Limb Ischemia, Anticoagulants
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anticoagulant and Apixaban, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 1 inclusion and 2 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 1 Apr 2020. 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 Israel. 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?
Anti Xa level of patients with atrial fibrillation and obesity while treatment of Apixaban. (time frame: 6 month). 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 1 Apr 2020.