Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement

Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement: A Randomized, Enoxaparin-controlled, Open Label, Dose-escalation Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00408239

Acronym

PEARL-1

Enrollment

367

Registered

2006-12-06

Start date

2006-12-31

Completion date

2009-03-31

Last updated

2011-12-19

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

Conditions

Thromboembolism

Keywords

Factor Xa inhibitor, Thromboembolism, Arthroplasty, Knee Replacement, Prevention and Control

Brief summary

Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery

Interventions

DRUGYM150

Oral

DRUGenoxaparin

Sub cutaneous

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Scheduled for elective primary total knee replacement surgery * Legal minimum age requirement ( country-specific) * Written informed consent has been obtained

Exclusion criteria

* Documented history or considered to be at increased risk of venous thromboembolism * Subjects considered to be at increased risk of bleeding: * Known hemorrhagic disorder and/or coagulation disorder * Thrombocytopenia * Clinically important bleeding occurred within 3 months prior to the screening visit * Acute bacterial endocarditis * Severe hypertension * Retinopathy * Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.

Design outcomes

Primary

Measure	Time frame
All clinically relevant bleeds during treatment rated as major or clinically relevant non-major, and/or incidence of death due to any cause during study treatment	2 Weeks

Secondary

Measure	Time frame
Venous thromboembolism and/or bleeds	2 Weeks
Other safety assessments	2 Weeks
PK, PD variables	2 Weeks

Countries

Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026