NCT00259662CompletedNot Applicable
High-dose Statin Therapy in the Perioperative Period and DVT Prevention.
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Decrease in incidence of deep vein thrombosis
Study Overview
Brief Summary
This study is designed to determine if the use of atorvastatin (Lipitor), a member of the HMG coA reductase inhibitor class of drugs referred to as statins, will reduce inflammatory responses and deep vein thrombosis formation when given in high doses in the perioperative period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •gynecologic tumor scheduled for resection
Exclusion Criteria
- •prior reaction to statins
- •renal insufficiency
- •liver disease
- •h/o alcoholism
- •prior h/o DVT or hypercoagulability
- •concurrent medications that significantly affect cytochrome P450 3A4
- •breast feeding or pregnancy
Outcomes
Primary Outcomes
Decrease in incidence of deep vein thrombosis
Secondary Outcomes
- Decrease in inflammatory mediator release.
Investigators
Study Sites (1)
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