Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

Astellas

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: YM150; Drug: warfarin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00448214

150-CL-030

Details and patient eligibility

About

To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population

Enrollment: 448 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects are eligible for the study if all of the following apply:

• Subject has paroxysmal permanent or persistent NVAF
• Subject has INR of 2.0 or below and an aPTT ≤ 1.5 times the upper limit of normal at the baseline visit.
• Legal minimum age requirement (country-specific).
• Written informed consent has been obtained.

Exclusion criteria

• History of heart valve disorders
• History of rheumatic fever.
• History of stroke and/or systemic embolism (including TIA).
• History of Acute Coronary Syndrome (ACS).
• Indication for warfarin other than NVAF.
• Known hemorrhagic disorder and/or coagulation disorder.
• Active bleeding or any condition associated with increased risk of bleeding.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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448 participants in 4 patient groups

1

Experimental group

Description:

Low dose

Treatment:

Drug: YM150

2

Experimental group

Description:

Middle dose

Treatment:

Drug: YM150

3

Experimental group

Description:

High dose

Treatment:

Drug: YM150

4

Active Comparator group

Treatment:

Drug: warfarin