Phase 4
N=16
Vorapaxar in the Human Endotoxemia Model
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT02875028 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Changes in Prothrombin Fragments F1+2 — 1315; 2530 pmol/L — p=0.029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vorapaxar (Drug); Placebo (Drug); LPS (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Vienna
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Prothrombin Fragments F1+2 |
1315; 2530 | 0.029 sig |
| SECONDARY Protease Activated Receptor (PAR)-1 Expression on Platelets |
0.85; 0.83 | — |
| SECONDARY Thrombin-Antithrombin Complexes |
17.4; 32.3 | — |
| SECONDARY Plasmin-Antiplasmin Complexes |
745; 1437 | — |
| SECONDARY E-Selectin |
43.5; 76.5 | — |
| SECONDARY Von Willebrand Factor |
162; 234 | — |
| SECONDARY P-Selectin |
30.8; 33.1 | — |
| SECONDARY Interleukin 6 |
105; 180 | — |
| SECONDARY Tumor Necrosis Factor Alpha |
27; 75 | — |
| SECONDARY C-reactive Protein |
1.53; 2.44 | — |
| SECONDARY Platelet Factor 4 |
53310; 59803 | — |
| SECONDARY Thrombomodulin |
5.05; 5.29 | — |
Summary
Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet inhibition may also exert positive results on coagulation activation and may beneficially influence the inflammatory response. Since vorapaxar is the first available substance of a new class of platelet inhibitors its effects on the human coagulation system and the inflammatory response will be assessed in the well-established human endotoxemia model.
Eligibility Criteria
Inclusion Criteria
- ≥18 years of age
- ≥60 kg bodyweight
- Normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant
- Willingness to comply with the trial's safety demands (to refrain from excessive sporting activities two weeks after Vorapaxar intake, i.e. full contact sports, climbing, mountain biking etc.)
- Ability to understand the purpose and nature of the study, as well as the associated risks No planned surgeries or other medical interventions in the planned study period
Exclusion Criteria
- Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e. platelet inhibitors, anticoagulants, CYP3A4 inhibitors, NSAIDs, selective serotonin reuptake inhibitors, selective noradrenaline and serotonin reuptake inhibitors)
- Positive results of HIV or hepatitis virology
- Acute illness with systemic inflammatory reactions
- Known allergies, hypersensitivities or intolerances to any of the used substances
- Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator
- History of stroke, transient ischemic attacks or intracerebral hemorrhage
- Known coagulation or platelet disorders
- Participation in an LPS trial within 6 weeks of the first study day
- Severe liver or kidney dysfunction
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT02875028). 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.