Gastric Bypass Status
Conditions
Keywords
gastric bypass, rivaroxaban, pharmacodynamics
Brief summary
The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied. The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups 1. Non obese people who have not had a gastric bypass. 2. Obese people who have not had a gastric bypass 3. People who have had a gastric bypass 4. People who are planning to undergo gastric bypass surgery in the near future who are willing to be studied before and after the bypass. The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.
Interventions
DRUGrivaroxaban
Single dose pharmacodynamic study
Sponsors
State University of New York - Upstate Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers in one of four groups 1. Normal weight and not having prior gastric bypass surgery, 2. Obese and not having prior gastric bypass surgery, 3. Subjects with prior roux en Y gastric bypass surgery, 4. Obese and planning to undergo roux en Y gastric bypass
Exclusion criteria
* Active renal or liver disease, * bleeding diathesis, * concurrent treatment with anticoagulants or aspirin, * indication for aspirin or anticoagulant treatment, * gastrointestinal bleeding, * uncontrolled hypertension, * active malignancy, * anemia, * thrombocytopenia, * pregnant, * allergy to rivaroxaban, * coagulopathy or any other medical condition that would increase risk to the subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| median inhibition of factor xa inhibition | 24 hours | pharmacodynamic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| median prolongation of prothrombin time | 24 hours | pharmacodynamic |
Countries
United States
Outcome results
None listed