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

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Astellas

Status and phase

Completed
Phase 2

Conditions

Thromboembolism

Treatments

Drug: enoxaparin
Drug: YM150

Study type

Interventional

Funder types

Industry

Identifiers

NCT00408239
150-CL-029

Details and patient eligibility

About

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

Enrollment

367 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

367 participants in 3 patient groups

1
Experimental group
Description:
Dose regimen 1
Treatment:
Drug: YM150
2
Active Comparator group
Treatment:
Drug: enoxaparin
3
Experimental group
Description:
Dose regimen 2
Treatment:
Drug: YM150

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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