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The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
The study will address the impact of genetical variation of a protein involved in the intestinal absorption of two new anticoagulants : Dabigatran etexilate and Rivaroxaban.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D->R->C+R | Active Comparator | sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with rivaroxaban |
|
| D->R->C+D | Active Comparator | sequence of treatment: Dabigatran after rivaroxaban after chlarythromycin in association with Dabigatran |
|
| R->D->C+D | Active Comparator | sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with Dabigatran |
|
| R->D->C+R | Active Comparator | sequence of treatment: rivaroxaban after Dabigatran after chlarythromycin in association with rivaroxaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D->R->C+R | Drug | one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of plasma concentrations of the drugs | over 24h after single oral dose |
| Measure | Description | Time Frame |
|---|---|---|
| PKD of the drugs | over 24h after single oral dose |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Blanchard, MD | CIC HEGP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC Hopital europeen george pompidou | Paris | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33369212 | Derived | Foulon-Pinto G, Jourdi G, Perrin J, Abdoul J, Paris G, Gouin-Thibault I, Curis E, Lecompte T, Siguret V. Study of thrombin generation with St Genesia to evaluate xaban pharmacodynamics: Analytical performances over 18 months. Int J Lab Hematol. 2021 Aug;43(4):821-830. doi: 10.1111/ijlh.13443. Epub 2020 Dec 28. | |
| 31157746 | Derived |
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| D->R->C+D | Drug | one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg |
|
| R->D->C+D | Drug | RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg |
|
| R->D->C+R | Drug | RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg |
|
| Marques P, Courand PY, Gouin-Thibault I, Zhygalina V, Bergerot D, Salem JE, Funck-Brentano C, Loriot MA, Azizi M, Blanchard A. P-glycoprotein influences urinary excretion of aldosterone in healthy individuals. J Hypertens. 2019 Nov;37(11):2225-2231. doi: 10.1097/HJH.0000000000002150. |