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High-dose Periop Statins for Prevention of DVT

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ClinicalTrials.gov Identifier: NCT00259662
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : December 1, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Gynecologic Oncological Pelvic/Abdominal Surgery Drug: atorvastatin

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: High-dose Statin Therapy in the Perioperative Period and DVT Prevention.
Study Start Date : November 2005
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Statins
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Decrease in incidence of deep vein thrombosis

Secondary Outcome Measures :
  1. Decrease in inflammatory mediator release.

Eligibility Criteria

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 Posted: November 29, 2005    Key Record Dates
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