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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00074828
First received: December 19, 2003
Last updated: March 27, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Total Knee Replacement
Total Hip Replacement
Drug: LY517717
Drug: enoxaparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 [ Time Frame: end of study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability, major and minor bleeding, death due to VTE, effect on QTc duration, AEs and SAEs, hepatobiliary and other safety lab parameters [ Time Frame: baseline, daily during therapy, at follow up visit ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics and pharmacodynamics [ Time Frame: predose, daily during therapy ] [ Designated as safety issue: No ]
  • Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE [ Time Frame: end of study drug administration ] [ Designated as safety issue: No ]
  • Compare the effect of LY517717 versus enoxaparin with confirmed VTE [ Time Frame: end of study drug administration ] [ Designated as safety issue: No ]
  • Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE [ Time Frame: through follow up ] [ Designated as safety issue: No ]

Enrollment: 511
Study Start Date: December 2003
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: A Drug: LY517717
Active Comparator: B Drug: enoxaparin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074828

Locations
Australia, Western 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, 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, Austria
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, Belgium
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, Czech Republic
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, Germany
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, Hungary
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, Italy
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, Poland
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00074828     History of Changes
Other Study ID Numbers: 8113, H8G-MC-EPBB
Study First Received: December 19, 2003
Last Updated: March 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
elective
primary unilateral

Additional relevant MeSH terms:
Anticoagulants
Enoxaparin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 23, 2014