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Completed

NCT Number: NCT00074828

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

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.

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Key information

Conditions

Total Knee Replacement Total Hip Replacement

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY517717

Drug

Enoxaparin

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Pharmacokinetics and pharmacodynamics

    Time frame: predose, daily during therapy

  3. Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE

    Time frame: end of study drug administration

  4. Compare the effect of LY517717 versus enoxaparin with confirmed VTE

    Time frame: end of study drug administration

  5. Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE

    Time frame: through follow up

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2003
Study completion
2005
First posted
Dec 23, 2003
Registry last updated
Mar 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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