Direct Oral Anticoagulant Levels in Chinese Patients With Atrial Fibrillation - A Real- World Pharmacokinetic Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

Direct oral anticoagulants (DOACs) have emerged as safe and efficacious ischemic stroke prophylaxis for non-valvular atrial fibrillation (NVAF). All four DOACs - apixaban, dabigatran, edoxaban, and rivaroxaban - were shown to reduce the risk of major bleeding compared to warfarin. The predictable pharmacokinetic profiles of DOACs also favour their use over warfarin. Together with increasing AF incidence due to population ageing, increased AF detection, and territory-wide reimbursement schemes, DOAC prescriptions have been surging worldwide. In Hong Kong, more than 78,354 patients received DOAC from January 2009 through April 2021 according to the Hospital Authority registry. The more liberal use of DOACs has led to new issues that require a thorough understanding of ethnic-specific DOAC pharmacokinetic profiles. For instance, 12- 15% of anticoagulated patients annually required interventional procedures that involve temporary discontinuation of DOAC for 48 hours or more. Although guideline-based periprocedural DOAC interruption resulted in a low 30-day thromboembolism rate of 0.16% - 0.6% in a Caucasian cohort, same measures for elective colonoscopies in a local population-based study resulted in a 30-day periprocedural thromboembolism rate of up to 2.2%. Although these studies cannot be compared directly, the remarkable interethnic discrepancy between the two cohorts warrants further pharmacokinetic and pharmacogenomic studies. More importantly, quantifying residual DOAC levels during the interruption periods may imply on duration of periprocedural DOAC interruption, length of hospital-stay, and the risk of thromboembolic and bleeding complications. Mapping inter- and intra-individual variations in DOAC levels may also impact on the management of ischemic stroke among DOAC recipients. Epidemiological studies have shown alarmingly up to 13% of acute ischemic stroke patients were on anticoagulation prior to stroke onset with increasing number of DOAC. These patients received low rates of recanalization therapy due to apprehension of bleeding complications, thus compromised survival and neurological recovery. A prospective study that reveals Asian-specific DOAC pharmacokinetic profiles may inform cross-disciplinary, territory-wide periprocedural care and acute stroke intervention strategy for the rapidly expanding DOAC population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Chinese nonvalvular atrial fibrillation (NVAF) patients on apixaban, dabigatran, edoxaban, or rivaroxaban for 6 months or more.

• Patients aged 18-80 years old.

• Patients who are able to provide an informed consent.

• Patients who are indicated for elective medical procedures that require interruption of direct oral anticoagulants (DOAC) for 48 hours.

Locations
Other Locations
Hong Kong Special Administrative Region
Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Bonaventure Yiu Ming IP, MB ChB
bonaventureip@cuhk.edu.hk
852-28902002
Backup
Thomas Wai Hong LEUNG, MB ChB
drtleung@cuhk.edu.hk
852-28902002
Time Frame
Start Date: 2022-09-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 427
Treatments
DOAC Recipients
We shall recruit the DOAC recipients that meet the following inclusion criteria:~1. Chinese NVAF patients on apixaban, dabigatran, edoxaban, or rivaroxaban for 6 months or more.~2. Patients aged 18-80 years old.~3. Patients who are able to provide an informed consent.~4. Patients who are indicated for elective medical procedures that require interruption of DOAC for 48 hours, such as colonoscopy, pleural biopsy, cardiac catheterization, digital subtraction angiograph, etc.
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov