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

Primary Purpose

Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
enoxaparin
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Factor Xa inhibitor, Thromboembolism, Arthroplasty, Knee Replacement, Prevention and Control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Dose regimen 1

Dose regimen 2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Venous thromboembolism and/or bleeds
Other safety assessments
PK, PD variables

Full Information

First Posted
December 4, 2006
Last Updated
December 15, 2011
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00408239
Brief Title
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
Acronym
PEARL-1
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 Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism
Keywords
Factor Xa inhibitor, Thromboembolism, Arthroplasty, Knee Replacement, Prevention and Control

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dose regimen 1
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Experimental
Arm Description
Dose regimen 2
Intervention Type
Drug
Intervention Name(s)
YM150
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
enoxaparin
Intervention Description
Sub cutaneous
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Venous thromboembolism and/or bleeds
Time Frame
2 Weeks
Title
Other safety assessments
Time Frame
2 Weeks
Title
PK, PD variables
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Jakarta
ZIP/Postal Code
14460
Country
Indonesia
City
Chubu region
Country
Japan
City
Chugoku region
Country
Japan
City
Kansai region
Country
Japan
City
Kanto region
Country
Japan
City
Kyushyu region
Country
Japan
City
Shikoku region
Country
Japan
City
Tohoku region
Country
Japan
City
In Cheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
City
Jeonnam
ZIP/Postal Code
519-809
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
City
Manila
ZIP/Postal Code
1008
Country
Philippines
City
Quezon City
ZIP/Postal Code
1114
Country
Philippines
City
Singapore
Country
Singapore
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
City
Bangkok
Country
Thailand
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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