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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
New Oral Anticoagulant Therapy for the Prevention of Blood Clots Following Hip or Knee Replacement Surgery
Scientific 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
Secondary ID [1] 0 0
Secondary ID [2] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Total Knee Replacement 0 0
Total Hip Replacement 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - LY517717
Treatment: Drugs - enoxaparin

Experimental: A -

Active Comparator: B -

Treatment: Drugs: LY517717

Treatment: Drugs: enoxaparin

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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
Timepoint [1] 0 0
end of study drug administration
Secondary outcome [1] 0 0
Safety and tolerability, major and minor bleeding, death due to VTE, effect on QTc duration, AEs and SAEs, hepatobiliary and other safety lab parameters
Timepoint [1] 0 0
baseline, daily during therapy, at follow up visit
Secondary outcome [2] 0 0
Pharmacokinetics and pharmacodynamics
Timepoint [2] 0 0
predose, daily during therapy
Secondary outcome [3] 0 0
Compare the effect of LY517717 versus enoxaparin measured by DVT, Proximal DVT, Distal DVT and PE
Timepoint [3] 0 0
end of study drug administration
Secondary outcome [4] 0 0
Compare the effect of LY517717 versus enoxaparin with confirmed VTE
Timepoint [4] 0 0
end of study drug administration
Secondary outcome [5] 0 0
Compare the effect of LY517717 versus enoxaparin measured by all confirmed VTEs and /or clinically suspected and confirmed VTE
Timepoint [5] 0 0
through follow up

Key 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.
Minimum age
18 Years
Maximum age
75 Years
Both males and females
Can healthy volunteers participate?
Key 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,

- Increased risk for blood clots.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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
Recruitment postcode(s) [1] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Country [4] 0 0
State/province [4] 0 0
Country [5] 0 0
State/province [5] 0 0
Country [6] 0 0
State/province [6] 0 0
Country [7] 0 0
State/province [7] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Eli Lilly and Company

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications