Recruitment

Recruitment Status
Terminated
Estimated Enrollment
48

Inclusion Criteria

Normal weight and not having prior gastric bypass surgery,
Obese and planning to undergo roux en Y gastric bypass
Obese and not having prior gastric bypass surgery,
...
Normal weight and not having prior gastric bypass surgery,
Obese and planning to undergo roux en Y gastric bypass
Obese and not having prior gastric bypass surgery,
Subjects with prior roux en Y gastric bypass surgery,

Exclusion Criteria

uncontrolled hypertension,
pregnant,
gastrointestinal bleeding,
...
uncontrolled hypertension,
pregnant,
gastrointestinal bleeding,
Active renal or liver disease,
active malignancy,
coagulopathy or any other medical condition that would increase risk to the subject
thrombocytopenia,
allergy to rivaroxaban,
anemia,
concurrent treatment with anticoagulants or aspirin,
indication for aspirin or anticoagulant treatment,
bleeding diathesis,

Summary

Conditions
Gastric Bypass Status
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Normal weight and not having prior gastric bypass surgery,
Obese and planning to undergo roux en Y gastric bypass
Obese and not having prior gastric bypass surgery,
...
Normal weight and not having prior gastric bypass surgery,
Obese and planning to undergo roux en Y gastric bypass
Obese and not having prior gastric bypass surgery,
Subjects with prior roux en Y gastric bypass surgery,

Exclusion Criteria

uncontrolled hypertension,
pregnant,
gastrointestinal bleeding,
...
uncontrolled hypertension,
pregnant,
gastrointestinal bleeding,
Active renal or liver disease,
active malignancy,
coagulopathy or any other medical condition that would increase risk to the subject
thrombocytopenia,
allergy to rivaroxaban,
anemia,
concurrent treatment with anticoagulants or aspirin,
indication for aspirin or anticoagulant treatment,
bleeding diathesis,

Locations

Syracuse, New York, 13210
Syracuse, New York, 13210

Tracking Information

NCT #
NCT02058199
Collaborators
Not Provided
Investigators
  • Principal Investigator: Thomas E Coyle, MD State University of New York - Upstate Medical University
  • Thomas E Coyle, MD State University of New York - Upstate Medical University