Rivaroxaban Effects in Subjects Who Have Undergone Gastric Bypass Surgery
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 48
Inclusion Criteria
- Obese and planning to undergo roux en Y gastric bypass
- Subjects with prior roux en Y gastric bypass surgery,
- Obese and not having prior gastric bypass surgery,
- ...
- Obese and planning to undergo roux en Y gastric bypass
- Subjects with prior roux en Y gastric bypass surgery,
- Obese and not having prior gastric bypass surgery,
- Normal weight and not having prior gastric bypass surgery,
Exclusion Criteria
- coagulopathy or any other medical condition that would increase risk to the subject
- anemia,
- pregnant,
- ...
- coagulopathy or any other medical condition that would increase risk to the subject
- anemia,
- pregnant,
- concurrent treatment with anticoagulants or aspirin,
- thrombocytopenia,
- indication for aspirin or anticoagulant treatment,
- uncontrolled hypertension,
- gastrointestinal bleeding,
- allergy to rivaroxaban,
- Active renal or liver disease,
- bleeding diathesis,
- active malignancy,
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
- Obese and planning to undergo roux en Y gastric bypass
- Subjects with prior roux en Y gastric bypass surgery,
- Obese and not having prior gastric bypass surgery,
- ...
- Obese and planning to undergo roux en Y gastric bypass
- Subjects with prior roux en Y gastric bypass surgery,
- Obese and not having prior gastric bypass surgery,
- Normal weight and not having prior gastric bypass surgery,
Exclusion Criteria
- coagulopathy or any other medical condition that would increase risk to the subject
- anemia,
- pregnant,
- ...
- coagulopathy or any other medical condition that would increase risk to the subject
- anemia,
- pregnant,
- concurrent treatment with anticoagulants or aspirin,
- thrombocytopenia,
- indication for aspirin or anticoagulant treatment,
- uncontrolled hypertension,
- gastrointestinal bleeding,
- allergy to rivaroxaban,
- Active renal or liver disease,
- bleeding diathesis,
- active malignancy,
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
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