High-dose Periop Statins for Prevention of DVT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Oncological Pelvic/Abdominal Surgery

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ala S Haddadin, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

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Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Lippi G, Favaloro EJ, Sanchis-Gomar F. Venous thrombosis associated with HMG-CoA reductase inhibitors. Semin Thromb Hemost. 2013 Jul;39(5):515-32. doi: 10.1055/s-0033-1343892. Epub 2013 Apr 29.

Reference Type DERIVED

PMID: 23629822 (View on PubMed)

Other Identifiers

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HIC0507000393

Identifier Type: -

Identifier Source: org_study_id