Oral AnticoagulantLOAFNCT04684056
Laboratory Assessment of the Concentration of Direct Oral Anticoagulants in Patients With Atrial Fibrillation
An observational study of Oral Anticoagulant and Atrial Fibrillation, run by Wuhan Asia Heart Hospital.
Trial summary
The incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Anticoagulant, Atrial Fibrillation, Pharmacokinetics and Pharmacodynamics
- How many people
- 1,864 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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: Catheter ablation was performed under general anesthesia in patients with NVAF. Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran )were administered peri-operatively to prevent thrombotic events.
Who may be able to join
- Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation
- Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.
Who cannot join
- Patients who have taken direct oral anticoagulants or warfarin before admission.
- Cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing Rivaroxaban after surgery.
- Abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity).
- Pregnant and lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants in Peri-operative Catheter Ablation for Patient With Atrial Fibrillation
The incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with AF, but studies have shown that DOAC are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. However, the pharmacokinetic and pharmacodynamic of DOAC during the peri-operative period of CAAF were lacking in China. The purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of DOAC in patients with peri-operative atrial fibrillation.
- Keywords
- Direct oral anticoagulants, pharmacokinetics and pharmacodynamics, Atrial Fibrillation, Rivaroxaban, Dabigatran, Edoxaban, Anti-FXa assays, Dilute thrombin time, Liquid-chromatography tandem mass spectrometry
- Medical subject headings
- Atrial Fibrillation
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 |
|---|---|---|
| Riva-control group | Routine concentration of Rivaroxaban (Peak) | |
| Riva-High group | High concentration of Rivaroxaban (Peak) | |
| Riva-Low group | low concentration of Rivaroxaban (Peak) | |
| Dabi-control group | Routine concentration of Dabigatran(Peak) | |
| Dabi-High group | High concentration of Dabigatran(Peak) | |
| Dabi-low group | low concentration of Dabigatran(Peak) | |
| Edo-control group | Routine concentration of Edoxaban(Peak) | |
| Edo-high group | High concentration of Edoxaban(Peak) | |
| Edo-low group | low concentration of Edoxaban(Peak) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of thromboembolic
Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC
Measured: Ninety days after catheter ablation
Bleeding Incidence
Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC
Measured: Ninety days after catheter ablation
Secondary outcomes (1)
Death from any cause
Measured: Ninety days after catheter ablation
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 start1 Jan 2021 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral 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
- 1,864 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Asia General Hospital (http://wagh.com.cn)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684056
- Sponsor's protocol ID
- 2020-YXKY-B010
- Acronym
- LOAF
- Status last verified
- Dec 2020
- First submitted
- 21 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Assessment of the Anticoagulant Activity of Direct Oral Anticoagulants in Peri-operative Catheter Ablation for Patient With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04684056
- Acronym / sponsor ID
- LOAF / 2020-YXKY-B010
- Keywords
- Direct oral anticoagulants, pharmacokinetics and pharmacodynamics, Atrial Fibrillation, Rivaroxaban, Dabigatran, Edoxaban, Anti-FXa assays, Dilute thrombin time
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,864 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Collaborators
- Wuhan Asia General Hospital (http://wagh.com.cn)
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (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 incidence of thromboembolic and bleeding event associated with catheter ablation for atrial fibrillation(CAAF) varies from 0.9% to 5% during peri-operative period. Direct oral anticoagulants (DOAC) (such as Rivaroxaban, Dabigatran and Edoxaban) are gradually applied in clinical practice to prevent thrombosis events in patients with AF, but studies have shown that DOAC are also affected by surgery, an invasive procedure, sub-therapeutic, food, renal function and age. However, the pharmacokinetic and pharmacodynamic of DOAC during the peri-operative period of CAAF were lacking in China. The purpose of this study was to evaluate the pharmacokinetics and pharmacokinetics of DOAC in patients with peri-operative atrial fibrillation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Riva-control group | – | –Routine concentration of Rivaroxaban (Peak) |
| Riva-High group | – | –High concentration of Rivaroxaban (Peak) |
| Riva-Low group | – | –low concentration of Rivaroxaban (Peak) |
| Dabi-control group | – | –Routine concentration of Dabigatran(Peak) |
| Dabi-High group | – | –High concentration of Dabigatran(Peak) |
| Dabi-low group | – | –low concentration of Dabigatran(Peak) |
| Edo-control group | – | –Routine concentration of Edoxaban(Peak) |
| Edo-high group | – | –High concentration of Edoxaban(Peak) |
| Edo-low group | – | –low concentration of Edoxaban(Peak) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Catheter ablation was performed under general anesthesia in patients with NVAF. Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran )were administered peri-operatively to prevent thrombotic events.
Key inclusion criteria (2 listed)
- Patients with Non-valvular atrial fibrillation(NVAF) undergoing catheter ablation
- Direct oral anticoagulants (Rivaroxaban, Edoxaban or Dabigatran)are administered peri-operatively during catheter ablation.
Key exclusion criteria (4 listed)
- Patients who have taken direct oral anticoagulants or warfarin before admission.
- Cross-replacement of oral anticoagulants, such as taking dabigatran before surgery and replacing Rivaroxaban after surgery.
- Abnormal coagulation tests (prothrombin time, partial thrombin time, thrombin time, antithrombin activity).
- Pregnant and lactating women.
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
Incidence of thromboembolic
Time frame: Ninety days after catheter ablation
Ischemic stroke, Deep vein thrombosis (DVT) or arterial thrombosis of any location after taking DOAC
Bleeding Incidence
Time frame: Ninety days after catheter ablation
Any bleeding, Especially gastrointestinal hemorrhage or hemoglobin drop is greater than 20g/L after taking DOAC
1 secondary outcome
Death from any cause
Time frame: Ninety days after catheter ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
Related trials for Oral Anticoagulant
RecruitingPhase 3
Thrombolysis in Factor Xa-inhibitors Trial
Stroke, Stroke (in Patients With Atrial Fibrillation)
Recruiting
Comparison of DOACs and LMWH for Thromboprophylaxis After Total Knee Arthroplasty
Total Knee Arthroplasty, Venous Thromboembolism
RecruitingPhase 3
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
Blood Loss, Surgical, Coagulation Disorder
RecruitingObservational study
Treatment Outcomes of Direct Oral Anticoagulants in Cerebral Venous Thrombosis in Vietnam
Cerebral Venous Thrombosis
Not yet recruitingPhase 4
Edoxaban Versus Apixaban in Cancer-Associated Venous Thromboembolism
Venous Thromboembolism, Active Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Anticoagulant and Atrial Fibrillation, run by Wuhan Asia Heart Hospital.
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 2 inclusion and 4 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 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Qingkun Fan, M.D (86+027-65796640, fqk@wahh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of thromboembolic (time frame: Ninety days after catheter ablation). The study lists 2 primary outcomes in all. 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 24 Dec 2020.