Atrial FibrillationNCT04684732
Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients
An observational study of Atrial Fibrillation, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to assess pharmacokinetics and pharmacodynamics of Apixaban and clinical outcome of Apixaban in Thai patients with nonvalvular atrial fibrillation with varying degree of creatinine clearance Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 241 participants
- Where
- 1 siteThailand
- Study dates
- 14 Dec 2020to Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Thai patients with nonvalvular atrial fibrillation receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, or systemic embolism.
Who may be able to join
- Patients with nonvalvular atrial fibrillation
- Patients who is receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
- Patients with nonvalvular atrial fibrillation
- Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Who cannot join
- Pregnant or lactating
- End stage renal disease patients who required chronic renal replacement therapy to sustained life
- History of acute kidney injury within the previous 3 months
- Severe hepatic impairment (Child-Pugh class C)
- Any gastrointestinal disorder that could impact the absorption of study drug
- CYP3A4 Moderate/Strong Inhibitors: ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, diltiazem, and St.John's Wort
- Part II
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
About this study
The purpose of this study is to assess pharmacokinetics and pharmacodynamics of Apixaban and clinical outcome of Apixaban in Thai patients with nonvalvular atrial fibrillation with varying degree of creatinine clearance
Read the detailed description
This study is divided into two parts.
The first part is a multiple dose pharmacokinetic and pharmacodynamics study of Apixaban in patient with stable renal function. The primary purpose of this study is to provide a clear understanding of the effect of creatinine clearance on pharmacokinetics and pharmacodynamics of Apixaban among Thai patients with nonvalvular atrial fibrillation. To assess the pharmacokinetics and pharmacodynamics of Apixaban, This study will enroll 30 subjects who meet the inclusion criteria.
The second part of this study will retrospectively determine the occurrent of clinical outcome between patients who were prescribed apixaban dose concordant and discordant to the drug leaflet. A total of 241 subjects will be recruited. The follow up period will begin from the time of initiation of apixaban until occurrent of stoke, transient ischemic attack, systemic embolism, bleeding, or death.
- Conditions
- Atrial Fibrillation
- Keywords
- Apixaban, Pharmacokinetic, Pharmacodynamic, Cardioembolic stroke, Ischemic stroke
- Medical subject headings
- Atrial Fibrillation, Embolic Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban dose concordant to leaflet | Patients who were prescribed apixaban dose concordant to apixaban leaflet approved by Thai FDA | |
| Apixaban dose discordant to leaflet | Patients who were prescribed apixaban dose discordant to apixaban leaflet approved by Thai FDA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
AUC(0-12) is measured by plasma concentration of apixaban over time. The mean are reported in nanogram hours per milliliter (ng*h/mL).
Measured: pre-dose to 12 hours post-dose
Secondary outcomes (2)
Number of participants with first event of stroke, transient ischemic attack, systemic embolism (SE), or all-cause death during the follow up period
Diagnosis of stroke is defined as the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE is defined as a clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
Number of patients with event of major or nonmajor (International Society on Thrombosis and Hemostasis [ISTH]) bleeding during the follow up period
ISTH major bleeding criteria is defined as a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.
ISTH nonmajor bleeding is defined as clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start14 Dec 2020
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University
- Responsible party
- Principal investigator, Pheeraphat Sarppreuttikun, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684732
- Sponsor's protocol ID
- 632/63
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2020
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- 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 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Renal Function and Pharmacokinetics of Apixaban and Clinical Outcome of Apixaban in Thai Non-valvular Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT04684732
- Acronym / sponsor ID
- 632/63
- Conditions
- Atrial Fibrillation
- Keywords
- Apixaban, Pharmacokinetic, Pharmacodynamic, Cardioembolic stroke, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Thammasat University
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 24 Dec 2020 (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.
The purpose of this study is to assess pharmacokinetics and pharmacodynamics of Apixaban and clinical outcome of Apixaban in Thai patients with nonvalvular atrial fibrillation with varying degree of creatinine clearance
Detailed description
This study is divided into two parts.
The first part is a multiple dose pharmacokinetic and pharmacodynamics study of Apixaban in patient with stable renal function. The primary purpose of this study is to provide a clear understanding of the effect of creatinine clearance on pharmacokinetics and pharmacodynamics of Apixaban among Thai patients with nonvalvular atrial fibrillation. To assess the pharmacokinetics and pharmacodynamics of Apixaban, This study will enroll 30 subjects who meet the inclusion criteria.
The second part of this study will retrospectively determine the occurrent of clinical outcome between patients who were prescribed apixaban dose concordant and discordant to the drug leaflet. A total of 241 subjects will be recruited. The follow up period will begin from the time of initiation of apixaban until occurrent of stoke, transient ischemic attack, systemic embolism, bleeding, or death.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban dose concordant to leaflet | – | –Patients who were prescribed apixaban dose concordant to apixaban leaflet approved by Thai FDA |
| Apixaban dose discordant to leaflet | – | –Patients who were prescribed apixaban dose discordant to apixaban leaflet approved by Thai FDA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thai patients with nonvalvular atrial fibrillation receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, or systemic embolism.
Key inclusion criteria (4 listed)
- Patients with nonvalvular atrial fibrillation
- Patients who is receiving a stable dose of apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
- Patients with nonvalvular atrial fibrillation
- Patients who was prescribed apixaban for primary or secondary prevention of stroke, transient ischemic attack, and systemic embolism.
Key exclusion criteria (8 listed)
- Pregnant or lactating
- End stage renal disease patients who required chronic renal replacement therapy to sustained life
- History of acute kidney injury within the previous 3 months
- Severe hepatic impairment (Child-Pugh class C)
- Any gastrointestinal disorder that could impact the absorption of study drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban
Time frame: pre-dose to 12 hours post-dose
AUC(0-12) is measured by plasma concentration of apixaban over time. The mean are reported in nanogram hours per milliliter (ng*h/mL).
2 secondary outcomes
Number of participants with first event of stroke, transient ischemic attack, systemic embolism (SE), or all-cause death during the follow up period
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
Number of patients with event of major or nonmajor (International Society on Thrombosis and Hemostasis [ISTH]) bleeding during the follow up period
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed until July 31, 2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Individual participant dataSharing planned: No
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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 Atrial Fibrillation, run by Chulalongkorn University at 1 site in Thailand.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 29 Jan 2021. 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 Thailand. 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?
Results are not available in the source record.
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?
Steady state area under the concentration-time curve from pre-dose to 12 hours post-dose (AUC(0-12)) of Apixaban (time frame: pre-dose to 12 hours post-dose). 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 29 Jan 2021.