A phase 3, randomised, double-blind, double dummy, parallel group, multi-centre, multi-national study for evaluation of efficacy and safety of du-176b verses warfarin in subjects with atrial fibrillation

A phase 3, randomised, double- blind, double dummy, parallel group, multi-center, multi-national study for evaluation of efficacy and safety of du-176b versus warfarin in subjects with atrial fibrillation

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000132246

Acronym

ENGAGE AF TIMI 48

Enrollment

16500

Registered

2009-02-25

Start date

2008-11-19

Completion date

Unknown

Last updated

2026-02-04

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

Conditions

None listed

Brief summary

A global study to assess the safety and effectiveness of a potential new drug in comparison to the standard practice of dosing with warfarin in those patients diagnosis of Atrial Fibrillation

Interventions

Intervention Arm 1: Du-176b is taken once daily orally - 60mg Intervention Arm 2: Du-176b is taken once daily orally - 30mg The overall duration for intervention 1 and 2 is taken once daily orally for approximately 2 years

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Male or female subjects with age = 21 years; 2. Able to provide written informed consent; 3. History of Atrial Fibrillation (AF) documented by a 12-lead electrocardiographic reading and/or continuous electrocardiogram (ECG) (e.g., Holter monitoring) consistent with Atrial Fibrillation (AF) (notation of AF as the abnormal rhythm on the local ECG report with evidence of irregularly irregular rhythm and an absence of P-waves on the ECG for diagnosis of AF) within the prior 12 months and for which anticoagulation therapy is indicated and planned for the duration of the study, including subjects with paroxysmal, persistent, or permanent AF and subjects with or without previous vitamin K antagonist (VKA) (including warfarin) experience (it is anticipated that approximately 40% of subjects will be VKA-naive); 4. A moderate to high risk of stroke, as defined by Scoring system Congestive Heart Failure, Hypertension, Age, Diabetes, previous stroke (CHADS2) index score of at least 2, is required to be eligible for the study. The CHADS2 scoring is performed by assigning 1 point each for a history of congestive heart failure, hypertension, age 75 years, or diabetes mellitus; and by assigning 2 points for history of stroke or Trans Ischemic Attack (TIA).

Exclusion criteria

1 Transient AF secondary to other reversible disorders 2 Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve 3 Subjects with any contraindication for anticoagulant agents; 4 Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders 5 Females of childbearing potential including the following: a)Females with a history of tubal-ligation; b) Females less than 2 years post-menopausal

Outcome results