Phase 2
Completed N=958
Odiparcil For The Prevention Of Venous Thromboembolism
Deep Vein Thrombosis · Fibrillation, Atrial · Venous Thromboembolism · Chronic Obstructive Pulmonary Disease
Source: ClinicalTrials.gov NCT00244725 ↗
Enrolled (actual)
958
Serious AEs
5.2%
Results posted
May 2017
Primary outcomePrimary: Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment — 45.1; 44.4; 41.3; 31.2 Percentage of participants — p=0.012
Summary
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Total VTE Event Over 10 ± 2 Days of Treatment |
45.1; 44.4; 41.3; 31.2 | 0.012 sig |
| SECONDARY Percentage of Participants With Proximal DVT Over 10 ± 2 Days of Treatment |
1.8; 1.8; 4.4; 0.6; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Distal DVT Over 10 ± 2 Days of Treatment |
42.1; 43.8; 38.8; 30.6; 1.8; 0.0 | — |
| SECONDARY Percentage of Participants With PE Over 10 ± 2 Days of Treatment |
0.0; 0.0; 0.0; 0.0; 1.2; 0.6 | — |
| SECONDARY Number of Death Due to VTE Over 10 ± 2 Days of Treatment |
0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Total Asymptomatic VTE Over 10 ± 2 Days of Treatment |
42.1; 43.8; 40.0; 30.6 | — |
| SECONDARY Percentage of Total Symptomatic VTE Over 10 ± 2 Days of Treatment |
1.8; 0.0; 1.3; 0.0 | — |
| SECONDARY Concentration of Trough Anti-IIa Activity Over the Duration of Treatment and Follow-up |
2.44; 3.15; 3.75; 0.26; 1.73; 2.43 | — |
| SECONDARY Percentage of Participants With Major Bleeds Over 10 ± 2 Days of Treatment |
0.0; 0.0; 0.9; 1.0 | — |
| SECONDARY Percentage of Participants With VTE and/or Major Bleeding Over 10±2 Days of Treatment |
45.1; 44.4; 42.5; 32.5; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Total VTE Any Time After Start of Treatment |
46.5; 45.8; 43.3; 30.4 | — |
| SECONDARY Percentage of Participants With Elevated Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Direct Bilirubin (DB) and Total Bilirubin (TB) by 2 Fold and 3 Fold From Upper Normal Limits (ULN) Any Time On-treatment |
4.8; 3.8; 3.8; 5.6; 0.9; 2.6 | — |
Eligibility Criteria
Inclusion Criteria
- Women must be unable to have children.
- Will have a total knee replacement.
Exclusion Criteria
- Allergic to any X-ray dye.
- Allergies or reactions to warfarin or coumadin.
- Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
- On anticoagulation therapy.
- Renal impairment.
- Participated in any clinical trial in the past 30 days.
Data sourced from ClinicalTrials.gov (NCT00244725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.