Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery

NCT02058199 | Terminated Phase 1

• 1 other identifier: SUNYUMU-rivpd-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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. 1.Non obese people who have not had a gastric bypass.
2. 2.Obese people who have not had a gastric bypass
3. 3.People who have had a gastric bypass
4. 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.

Conditions

Gastric Bypass Status

Keywords

gastric bypass; rivaroxaban; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• median inhibition of factor xa inhibition

  pharmacodynamic

  24 hours

Secondary Outcomes (1)

• median prolongation of prothrombin time

  24 hours

Study Arms (4)

normal subjects

EXPERIMENTAL

A single dose of 10 mg of rivaroxaban will be administered

Drug: rivaroxaban

Obese non bypassed

EXPERIMENTAL

A single dose of rivaroxaban will be administered

Drug: rivaroxaban

obese bypassed

EXPERIMENTAL

A single dose of rivaroxaban will be administered

Drug: rivaroxaban

pre and post bypassed subject

EXPERIMENTAL

A single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass

Drug: rivaroxaban

Interventions

rivaroxaban DRUG

Single dose pharmacodynamic study

Also known as: Xarelto

Obese non bypassed; normal subjects; obese bypassed; pre and post bypassed subject

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers in one of four groups
• Normal weight and not having prior gastric bypass surgery,
• Obese and not having prior gastric bypass surgery,
• Subjects with prior roux en Y gastric bypass surgery,
• Obese and planning to undergo roux en Y gastric bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

Rivaroxaban

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Thomas E Coyle, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 7, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 5, 2016

Record last verified: 2015-01

Locations

US (1)