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OpenTrials
Completed

NCT Number: NCT00259662

High-dose Periop Statins for Prevention of DVT

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.

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Key information

Conditions

Gynecologic Oncological Pelvic/Abdominal Surgery Adnexal Diseases Cardiovascular Diseases Embolism and Thrombosis Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Thrombosis Urogenital Diseases Urogenital Neoplasms Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Primary outcomes

  1. Decrease in incidence of deep vein thrombosis

Secondary outcomes

  1. Decrease in inflammatory mediator release.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Washington Mutual Foundation

Registry information

Official study title

High-dose Statin Therapy in the Perioperative Period and DVT Prevention.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 29, 2005
Registry last updated
Dec 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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