Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

High-Dose Periop Statins for Prevention of DVT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2005 by Yale University.
Recruitment status was  Recruiting
Washington Mutual Foundation
Information provided by:
Yale University Identifier:
First received: November 28, 2005
Last updated: November 30, 2005
Last verified: November 2005

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-Blind
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.

Estimated Enrollment: 150
Study Start Date: November 2005

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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 medicatins that signicantly affect cytochrome P450 3A4
  • breast feeding or pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00259662

Contact: Ala S Haddadin, MD 203-785-2802
Contact: Jessica L Feinleib, MD/Phd

United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Ala S Haddadin, MD    203-785-2802   
Principal Investigator: Ala S Haddadin, MD         
Sponsors and Collaborators
Yale University
Washington Mutual Foundation
Principal Investigator: Ala S Haddadin, MD Assistant Professor
  More Information

No publications provided by Yale University

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00259662     History of Changes
Other Study ID Numbers: HIC0507000393
Study First Received: November 28, 2005
Last Updated: November 30, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
deep vein thrombosis
statin therapy in perioperative period processed this record on February 27, 2015