High-Dose Periop Statins for Prevention of DVT

This study is currently recruiting participants.

Verified by Yale University, November 2005

Sponsors and Collaborators:	Yale University Washington Mutual Foundation
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00259662

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

MedlinePlus related topics: Deep Vein Thrombosis Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	High-Dose Statin Therapy in the Perioperative Period and DVT Prevention.

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.

Estimated Enrollment:	150
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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 medicatins that signicantly affect cytochrome P450 3A4
breast feeding or pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259662

Contacts

Contact: Ala S Haddadin, MD	203-785-2802	ala.haddadin@yale.edu
Contact: Jessica L Feinleib, MD/Phd

Locations

United States, Connecticut
Yale-New Haven Hospital	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ala S Haddadin, MD 203-785-2802 ala.haddadin@yale.edu
Principal Investigator: Ala S Haddadin, MD

Sponsors and Collaborators

Yale University

Washington Mutual Foundation

Investigators

Principal Investigator:

Ala S Haddadin, MD

Assistant Professor

More Information

Study ID Numbers:	HIC0507000393
Study First Received:	November 28, 2005
Last Updated:	November 30, 2005
ClinicalTrials.gov Identifier:	NCT00259662
Health Authority:	United States: Food and Drug Administration

Keywords provided by Yale University:

cancer--ovarian
cancer--endometria
deep vein thrombosis
statin therapy in perioperative period

Study placed in the following topic categories:

Venous Thrombosis
Atorvastatin
Thrombosis

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009