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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001839-21 | EudraCT Number | ||
| 140096A-21 | Other Identifier | ANSM |
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Rivaroxaban is a direct oral anticoagulant that target specifically activated factor X. Bleeding events related to rivaroxaban are the consequence of physiopathologic, pharmacokinetic issues or poisoning. Few results are available on the use of activated charcoal in rivaroxaban poisoning. Moreover, a recent study, in healthy subjects, shows that activated charcoal can reduce significantly exposition to apixaban (a direct oral anticoagulant of the same class). The objective of this study is to evaluate the effect of activated charcoal on rivaroxaban pharmacokinetics. It corresponds to a randomised open trial with an incomplete cross over design (3 occasions). It will enrol 12 healthy subjects. Four treatments modalities will be studied: rivaroxaban alone and rivaroxaban with activated charcoal administrated 2, 4 or 8 hours after rivaroxaban administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
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| Arm B | Experimental | . Period " rivaroxaban and activated charcoal 5 hours after rivaroxaban administration"
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| Arm C | Experimental | . Period " rivaroxaban and activated charcoal 2 hours after rivaroxaban administration"
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rivaroxaban | Drug | rivaroxaban 40 mg/day (1 day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentrations of rivaroxaban | rivaroxaban pharmacokinetics | H0.5, H0.75, H1, H1.5, H2, H2.5, H3, H4, H5, H6, H8, H10, H12, H14, H18 and H24 after rivaroxaban administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick MISMETTI, MD PhD | CHU de SAINT-ETIENNE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE | Saint-Etienne | 42000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27910037 | Derived | Ollier E, Hodin S, Lanoiselee J, Escal J, Accassat S, De Magalhaes E, Basset T, Bertoletti L, Mismetti P, Delavenne X. Effect of Activated Charcoal on Rivaroxaban Complex Absorption. Clin Pharmacokinet. 2017 Jul;56(7):793-801. doi: 10.1007/s40262-016-0485-1. |
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| ID | Term |
|---|---|
| D000881 | Anthrax |
| D011041 | Poisoning |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| rivaroxaban and activated charcoal |
| Drug |
rivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day) |
|
| D007239 | Infections |
| D064419 | Chemically-Induced Disorders |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |