Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery

NCT ID: NCT02058199

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-12-31

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.

Conditions

Gastric Bypass Status

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

normal subjects

A single dose of 10 mg of rivaroxaban will be administered

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

Single dose pharmacodynamic study

Obese non bypassed

A single dose of rivaroxaban will be administered

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

Single dose pharmacodynamic study

obese bypassed

A single dose of rivaroxaban will be administered

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

Single dose pharmacodynamic study

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

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

Single dose pharmacodynamic study

Interventions

rivaroxaban

Single dose pharmacodynamic study

Intervention Type: DRUG

Other Intervention Names

Xarelto

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E Coyle, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

SUNYUMU-rivpd-001

Identifier Type: -

Identifier Source: org_study_id