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OpenTrials
Completed

NCT Number: NCT00408239

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

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

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jakarta, Indonesia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

YM150

Drug

Oral

Enoxaparin

Drug

Sub cutaneous

Primary outcomes

  1. 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

    Time frame: 2 Weeks

Secondary outcomes

  1. Venous thromboembolism and/or bleeds

    Time frame: 2 Weeks

  2. Other safety assessments

    Time frame: 2 Weeks

  3. PK, PD variables

    Time frame: 2 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

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

Acronym: PEARL-1

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Dec 6, 2006
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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