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

Phase 2

Completed

• Conditions: Total Knee Replacement; Total Hip Replacement
• Interventions: Drug: LY517717; Drug: enoxaparin

• Registration Number: NCT00074828
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2003-12-19
• Study First Submitted QC: 2003-12-22
• Study First Posted: 2003-12-23
• Study Completion: 2005-05
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-27
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	LY517717	-
B	enoxaparin	-

Primary Outcome Measures

Name	Time	Method
Efficacy of LY517717 to enoxaparin in the prevention of VTEs measured by the proportion of patients with VTE event (DVT and/or PE) as confirmed by bilateral venography or on clinical assessment	end of study drug administration

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability, major and minor bleeding, death due to VTE, effect on QTc duration, AEs and SAEs, hepatobiliary and other safety lab parameters	baseline, daily during therapy, at follow up visit
Pharmacokinetics and pharmacodynamics	predose, daily during therapy
Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE	end of study drug administration
Compare the effect of LY517717 versus enoxaparin with confirmed VTE	end of study drug administration
Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE	through follow up

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇵🇱 Bydgoszcz, Poland