Variation of CES1 and ABCB1 gene in patients received dabigatran at Phramongkutklao Hospital

Phase 4

• Conditions: Dabigatran was used to prevent thromboembolism in Thai AF patients but data about the variation of genetics are limited; dabigatran genetics therapeutic drug monitoring

• Registration Number: TCTR20220211007
• Lead Sponsor: Faculty of Pharmacy, Silpakorn University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-11
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Thai patients age more than 20 years old
Received dabigatran at least 7 days
Good compliance 100 percent
The patient signed inform consent

Exclusion Criteria

Patients with mechanical valve replacement or moderate to severe mitral stenosis
Child Pugh B or Child Pugh C
Pregnancy and lactation
Psychiatric patients or no caregiver
ESRD patients or eGFR less than 15 ml/min

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dabigatran level 1 month Chromogenic assay,gene variation of ABCB1 and CES1 1 month polymerase chain reaction (PCR)

Secondary Outcome Measures

Name	Time	Method
clinical outcome 1 year rate of ischemic stroke and bleeding outcome