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
Sponsor:
Collaborator:
Washington Mutual Foundation
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00259662
First received: November 28, 2005
Last updated: November 30, 2005
Last verified: November 2005
  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-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
  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
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 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

No publications provided by Yale University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
cancer--ovarian
cancer--endometria
deep vein thrombosis
statin therapy in perioperative period

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

ClinicalTrials.gov processed this record on October 23, 2014