Comparative effectiveness and safety of branded and generic apixaban among patients with atrial fibrillation in Thailand

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250307002

Enrollment

534

Registered

2025-03-07

Start date

2025-04-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients aged 18 years or older diagnosed with atrial fibrillation by electrocardiogram and CHA2DS2-VASc score greater than or equal to 2. atrial fibrillation, AF, CHA2DS2-VASc score

Interventions

Group 1 Patient with generic apixaban take every day for 12 months.,Group 2 Patient with branded apixaban for prevent thrombosis resulting from atrial fibrillation for at least 6 months, there is a hi

Experimental Drug,Experimental Drug

Generic apixaban ,Branded Apixaban

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years or older diagnosed with atrial fibrillation by electrocardiogram. 2. CHA2DS2-VASc score greater than or equal 2.

Exclusion criteria

Exclusion criteria: 1.Reversible causes of AF. 2.Moderate-to-severe mitral stenosis. 3.Mechanical heart valve implantation. 4.Severe renal impairment 5.History of apixaban allergy. 6.Concomitant use of high-dose aspirin or dual antiplatelet therapy. 7.Active bleeding or unexplained anemia. 8.History of major bleeding events while on DOACs. 9.Platelet count lower than 100,000 cells. 10.Liver dysfunction (ALT greater than 3 times the upper limit of normal (ULN) or hyperbilirubinemia). 11.Use of Herbal products or dietary supplements containing St. Johns wort. 12.Use strong CYP3A4/P-gp inducer or inhibitor drugs. 12.Pregnancy. 13.Inability to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Net adverse clinical event (NACE); stroke, systemic embolism, major bleeding, death Every 3 months until 12 months follow up Clinical examination	—

Secondary

Measure	Time frame
Efficacy outcome : stroke, systemic embolism, death. Safety outcome: major bleeding, non-major bleeding (as defined by ISTH definition) Every 3 months until 12 months follow up Clinical examination	—

Countries

Thailand

Contacts

Public ContactAsst. Prof. Wipharak Rattanavipanon

Faculty of Pharmacy Mahidol University

wipharak.bun@mahidol.edu026448677

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026