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Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery

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ClinicalTrials.gov Identifier: NCT02058199
Recruitment Status : Terminated (PI left the Institution; No replacement PI identified;)
First Posted : February 7, 2014
Last Update Posted : January 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Gastric Bypass Status Drug: rivaroxaban Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Experimental: normal subjects
A single dose of 10 mg of rivaroxaban will be administered
Drug: rivaroxaban
Single dose pharmacodynamic study
Other Name: Xarelto

Experimental: Obese non bypassed
A single dose of rivaroxaban will be administered
Drug: rivaroxaban
Single dose pharmacodynamic study
Other Name: Xarelto

Experimental: obese bypassed
A single dose of rivaroxaban will be administered
Drug: rivaroxaban
Single dose pharmacodynamic study
Other Name: 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 Name: Xarelto




Primary Outcome Measures :
  1. median inhibition of factor xa inhibition [ Time Frame: 24 hours ]
    pharmacodynamic


Secondary Outcome Measures :
  1. median prolongation of prothrombin time [ Time Frame: 24 hours ]
    pharmacodynamic



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058199


Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Thomas E Coyle, MD State University of New York - Upstate Medical University

Responsible Party: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT02058199     History of Changes
Other Study ID Numbers: SUNYUMU-rivpd-001
First Posted: February 7, 2014    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2015

Keywords provided by State University of New York - Upstate Medical University:
gastric bypass
rivaroxaban
pharmacodynamics

Additional relevant MeSH terms:
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants