diseases requiring anticoagulation
Conditions
Interventions
PCC 50iu/kg for intravenous (i.v.) infusion or matching placebo
Apixaban 5 mg tablets or Edoxaban 60 mg tablets or Rivaroxaban 20 mg tablets.
Sponsors
VarmX B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Men and women of any ethnic origin aged between 50 and 79 years of age, inclusive, at the time of Screening. 2. Male subjects must be willing to use appropriate contraception, such as a condom, and to refrain from sperm donation during the study and until 90 days after study drug administration. 3. Women of childbearing potential must agree not to attempt to become pregnant and to use a highly effective form of birth control during the study and for 90 days after study drug administration when their sexual partner has not been vasectomized. Highly effective forms of birth control entail the use of combined (estrogen- and progestogen-containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, an intrauterine device (IUD), an intrauterine hormone-releasing system (IUS) or abstinence. 4. Postmenopausal women must have had >=12 months of spontaneous amenorrhea (with documented follicle-stimulating hormone (FSH) >=30 mIU/mL).
Exclusion criteria
Exclusion criteria: 1. The subject has taken piroxicam in the two weeks prior to the first administration of any study medication. 2. The subject has taken any non-aspirin non-piroxicam non-steroidal anti-inflammatory drug (NSAID) in the week prior to the first administration of any study medication. 3. The subject requires or has taken during the month prior to the first administration of any study medication, vitamin K for therapeutic reasons. Vitamin K not taken for therapeutic purposes is acceptable, e.g. as part of a multivitamin supplement. 4. The subject is receiving or requires, for any cause, any anticoagulant or antiplatelet therapy including warfarin, clopidogrel or aspirin or any other anticoagulant or antiplatelet agent or has used these therapies in the month prior to the first administration of any study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • PD parameters include: prothrombin time (PT) and activated partial thromboplastin time (aPTT), dilute Russell Viper Venom Time (dRVVT), dilute PT (dPT), D-dimer, and calibrated automated thrombography (thrombin generation). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Safety and tolerability parameters include: physical examination, adverse events (AEs), clinical laboratory assessments including hematology, serum chemistry, coagulation and urinalysis, vital signs, 12-lead electrocardiograms (ECGs), and local tolerability. • Plasma concentrations of DOAC and PCC components. | — |
Countries
Netherlands
Outcome results
None listed