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High-dose Periop Statins for Prevention of DVT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259662
First Posted: November 29, 2005
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Washington Mutual Foundation
Information provided by (Responsible Party):
Yale University
  Purpose
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.

Condition Intervention
Gynecologic Oncological Pelvic/Abdominal Surgery Drug: atorvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: High-dose Statin Therapy in the Perioperative Period and DVT Prevention.

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Decrease in incidence of deep vein thrombosis

Secondary Outcome Measures:
  • Decrease in inflammatory mediator release.

Enrollment: 29
Study Start Date: November 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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): NCT00259662


Locations
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Washington Mutual Foundation
Investigators
Principal Investigator: Ala S Haddadin, MD Assistant Professor
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00259662     History of Changes
Other Study ID Numbers: HIC0507000393
First Submitted: November 28, 2005
First Posted: November 29, 2005
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by Yale University:
cancer--ovarian
cancer--endometria
deep vein thrombosis
statin therapy in perioperative period

Additional relevant MeSH terms:
Atorvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors