---
title: Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
nct_id: NCT00448214
overall_status: COMPLETED
phase: PHASE2
sponsor: Astellas Pharma Inc
study_type: INTERVENTIONAL
primary_condition: Atrial Fibrillation
countries: Australia, Hong Kong, Japan, Malaysia, New Zealand, Singapore, South Africa, South Korea, Taiwan, Thailand
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00448214.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00448214"
ct_last_update_post_date: 2011-12-19
last_seen_at: "2026-05-12T07:27:10.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation

**Official Title:** Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation - A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Warfarin

**NCT ID:** [NCT00448214](https://clinicaltrials.gov/study/NCT00448214)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 448
- **Lead Sponsor:** Astellas Pharma Inc
- **Conditions:** Atrial Fibrillation
- **Start Date:** 2007-03
- **Completion Date:** 2008-10
- **CT.gov Last Update:** 2011-12-19

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **1** (EXPERIMENTAL) — Low dose
- **2** (EXPERIMENTAL) — Middle dose
- **3** (EXPERIMENTAL) — High dose
- **4** (ACTIVE_COMPARATOR)

## Interventions

- **YM150** (DRUG) — Oral
- **warfarin** (DRUG) — Oral

## Primary Outcomes

- **All clinically relevant bleeds during the treatment period rated as "major" or "clinically relevant non-major(CRNM)"** _(time frame: 16 Weeks)_

## Secondary Outcomes

- **Incidence of symptomatic stroke** _(time frame: 16 Weeks)_
- **Incidence of transient ischemic attack (TIA)** _(time frame: 16 Weeks)_
- **Incidence of systemic thromboembolic event** _(time frame: 16 Weeks)_
- **Incidence of the bleeding rates** _(time frame: 16 Weeks)_
- **Other safety assessments** _(time frame: 16 Weeks)_
- **PK, PD variables** _(time frame: 16 Weeks)_

## Locations (18)

- Launceston, Australia
- Pok Fu Lam, Hong Kong
- Shatin, Hong Kong
- Hokkaido, Japan
- Kansai, Japan
- Kanto, Japan
- Kyusyu, Japan
- Shikoku, Japan
- Tōhoku, Japan
- Kuala Lumpur, Malaysia
- Hastings, New Zealand
- Singapore, Singapore
- Bloemfontein, South Africa
- Seoul, South Korea
- Taipei, Taiwan
- Bangkok, Thailand
- Chiang Mai, Thailand
- Nakhon Ratchasima, Thailand

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|launceston||australia` — added _(2026-05-12)_
- `locations.|pok fu lam||hong kong` — added _(2026-05-12)_
- `locations.|shatin||hong kong` — added _(2026-05-12)_
- `locations.|hokkaido||japan` — added _(2026-05-12)_
- `locations.|kansai||japan` — added _(2026-05-12)_
- `locations.|kanto||japan` — added _(2026-05-12)_
- `locations.|kyusyu||japan` — added _(2026-05-12)_
- `locations.|shikoku||japan` — added _(2026-05-12)_
- `locations.|tōhoku||japan` — added _(2026-05-12)_
- `locations.|kuala lumpur||malaysia` — added _(2026-05-12)_
- `locations.|hastings||new zealand` — added _(2026-05-12)_
- `locations.|singapore||singapore` — added _(2026-05-12)_
- `locations.|bloemfontein||south africa` — added _(2026-05-12)_
- `locations.|seoul||south korea` — added _(2026-05-12)_
- `locations.|taipei||taiwan` — added _(2026-05-12)_
- `locations.|bangkok||thailand` — added _(2026-05-12)_
- `locations.|chiang mai||thailand` — added _(2026-05-12)_
- `locations.|nakhon ratchasima||thailand` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00448214.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00448214*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*