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Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery

NCT02058199 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-01-05

No results posted yet for this study

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.

Conditions

  • Gastric Bypass Status

Interventions

DRUG

rivaroxaban

Single dose pharmacodynamic study

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Thomas E Coyle, MD · State University of New York - Upstate Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02058199 on ClinicalTrials.gov