Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery
Status:
Terminated
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
State University of New York - Upstate Medical University