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Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement (PEARL-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00408239
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : December 19, 2011
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: YM150 Drug: enoxaparin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Study Start Date : December 2006
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Dose regimen 1
Drug: YM150
Oral
Active Comparator: 2 Drug: enoxaparin
Sub cutaneous
Experimental: 3
Dose regimen 2
Drug: YM150
Oral



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408239


Locations
Indonesia
Jakarta, Indonesia, 14460
Japan
Chubu region, Japan
Chugoku region, Japan
Kansai region, Japan
Kanto region, Japan
Kyushyu region, Japan
Shikoku region, Japan
Tohoku region, Japan
Korea, Republic of
In Cheon, Korea, Republic of, 405-760
Jeonnam, Korea, Republic of, 519-809
Seoul, Korea, Republic of, 110-744
Malaysia
Kelantan, Malaysia, 16150
Kuala Lumpur, Malaysia, 59100
Philippines
Manila, Philippines, 1008
Quezon City, Philippines, 1114
Singapore
Singapore, Singapore
Taiwan
Kaohsiung, Taiwan, 833
Thailand
Bangkok, Thailand
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00408239     History of Changes
Other Study ID Numbers: 150-CL-029
First Posted: December 6, 2006    Key Record Dates
Last Update Posted: December 19, 2011
Last Verified: December 2011

Keywords provided by Astellas Pharma Inc:
Factor Xa inhibitor
Thromboembolism
Arthroplasty
Knee Replacement
Prevention and Control

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Darexaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants