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

Total Knee Replacement Clinical Trial

Official title:

A Comparison of the Oral Anticoagulant LY517717 Difumarate to Subcutaneous Enoxaparin for the Prevention of Venous Thromboembolic Events (VTE) Post-Total Hip Replacement (THR) and Post-Total Knee Replacement (TKR) Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00074828
• Other study ID #: 8113
• Secondary ID: H8G-MC-EPBB
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2003
• Last updated: March 27, 2008
• Start date: December 2003
• Est. completion date: May 2005

Study information

• Verified date: March 2008
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Total Hip Replacement
• Total Knee Replacement

Intervention

Drug:
• LY517717

• enoxaparin

Locations

Country	Name	City	State
Australia	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.	Nedlands	Western Australia
Austria	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.	Vienna
Belgium	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.	Brussels
Czech Republic	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.	Ostrava-Poruba
Germany	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.	Aachen
Hungary	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.	Kecskemet
Italy	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.	Perugia
Poland	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czech Republic,  Germany,  Hungary,  Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Pharmacokinetics and pharmacodynamics		predose, daily during therapy	No
Secondary	Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE		end of study drug administration	No
Secondary	Compare the effect of LY517717 versus enoxaparin with confirmed VTE		end of study drug administration	No
Secondary	Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE		through follow up	No

External Links

•   Lilly Clinical Trial Registry