Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery

A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Gastric Bypass Status
• Intervention / Treatment: Drug: rivaroxaban

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: normal subjects; A single dose of 10 mg of rivaroxaban will be administered	Drug: rivaroxaban; Single dose pharmacodynamic study; Other Names: Xarelto
Experimental: Obese non bypassed; A single dose of rivaroxaban will be administered	Drug: rivaroxaban; Single dose pharmacodynamic study; Other Names: Xarelto
Experimental: obese bypassed; A single dose of rivaroxaban will be administered	Drug: rivaroxaban; Single dose pharmacodynamic study; Other Names: Xarelto
Experimental: pre and post bypassed subject; A single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass	Drug: rivaroxaban; Single dose pharmacodynamic study; Other Names: Xarelto

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
median inhibition of factor xa inhibition	pharmacodynamic	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
median prolongation of prothrombin time	pharmacodynamic	24 hours

Collaborators and Investigators

• Sponsor: State University of New York - Upstate Medical University
• Investigators: Principal Investigator: Thomas E Coyle, MD, State University of New York - Upstate Medical University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 7, 2014

Study Record Updates

• Last Update Posted (Estimate): January 5, 2016
• Last Update Submitted That Met QC Criteria: January 4, 2016
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: pharmacodynamics; rivaroxaban; gastric bypass
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: SUNYUMU-rivpd-001