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

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)

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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