Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery

Phase 1

Terminated

• Conditions: Gastric Bypass Status
• Interventions: Drug: rivaroxaban

• Registration Number: NCT02058199
• Lead Sponsor: State University of New York - Upstate Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-07
• Study Start: 2014-12
• Status Verified: 2015-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal subjects	rivaroxaban	A single dose of 10 mg of rivaroxaban will be administered
obese bypassed	rivaroxaban	A single dose of rivaroxaban will be administered
Obese non bypassed	rivaroxaban	A single dose of rivaroxaban will be administered
pre and post bypassed subject	rivaroxaban	A single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass

Primary Outcome Measures

Name	Time	Method
median inhibition of factor xa inhibition	24 hours	pharmacodynamic

Secondary Outcome Measures

Name	Time	Method
median prolongation of prothrombin time	24 hours	pharmacodynamic

Trial Locations

Locations (1)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States