New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery

Lilly

Status and phase

Completed

Phase 2

Conditions

Total Hip Replacement

Total Knee Replacement

Treatments

Drug: LY517717

Drug: enoxaparin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00074828

8113

H8G-MC-EPBB

Details and patient eligibility

About

LY517717 (a capsule given by mouth) is a blood thinner that may prevent blood clots from forming in the legs and may prevent those blood clots from traveling to the lungs. Leg and lung blood clots occur commonly after patients have surgery to replace a hip or knee joint. These clots often occur while patients are in bed in the hospital after hip or knee joint surgery. The purpose of this study is to test if different dose strengths (amount of drug in the capsules) of LY517717 can prevent blood clots from forming and to determine if LY517717 is safe. This study will compare LY517717 to enoxaparin, another blood thinner. Enoxaparin is one of the standard medications given after hip or knee joint surgery.

Enrollment

511 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Are scheduled for total knee or hip replacement surgery (only one side, first time joint replacement)
Are at least 18 years of age and no more than 75 years of age.
Have a body weight more than 50 kg and less than 120 kg.
Sign an approved Eli Lilly and Company informed consent document.

Exclusion criteria

Have had hip or knee replacement surgery in the non-surgical leg or any surgical procedure in the surgical leg within 6 months prior to enrollment.
Other surgeries (brain, spinal cord, eye within 12 months; chest or abdominal surgery within 1 month).
Have taken drugs that might increase possibility of bleeding.
Other risk factors for bleeding (bleeding disorders, abnormal results on blood tests, ulcers)
Increased risk for blood clots.