Gynecologic Oncological Pelvic/Abdominal SurgeryNCT00259662
High-dose Periop Statins for Prevention of DVT
A study testing atorvastatin in people with Gynecologic Oncological Pelvic/Abdominal Surgery, run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Oncological Pelvic/Abdominal Surgery
- What is being tested?
- atorvastatin
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Aug 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- gynecologic tumor scheduled for resection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: High-dose Statin Therapy in the Perioperative Period and DVT Prevention.
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.
- Being tested
- atorvastatin
- Keywords
- cancer--ovarian, cancer--endometria, deep vein thrombosis, statin therapy in perioperative period
- Medical subject headings
- Ovarian Neoplasms, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in incidence of deep vein thrombosis
Secondary outcomes (1)
Decrease in inflammatory mediator release.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic Oncological Pelvic/Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington Mutual Foundation
- Responsible party
- Sponsor
- Investigators
- Ala S Haddadin, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259662
- Sponsor's protocol ID
- HIC0507000393
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2005
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
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.
PubMed 23629822
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-dose Statin Therapy in the Perioperative Period and DVT Prevention.
- ClinicalTrials.gov ID
- NCT00259662
- Acronym / sponsor ID
- HIC0507000393
- Keywords
- cancer--ovarian, cancer--endometria, deep vein thrombosis, statin therapy in perioperative period
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Washington Mutual Foundation
- Study start
- Nov 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 29 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- gynecologic tumor scheduled for resection
Key exclusion criteria (7 listed)
- prior reaction to statins
- renal insufficiency
- liver disease
- h/o alcoholism
- prior h/o DVT or hypercoagulability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatin | Drug | – |
Primary outcome
Decrease in incidence of deep vein thrombosis
1 secondary outcome
Decrease in inflammatory mediator release.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Derived from this study: PubMed 23629822Lippi 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.
Related trials for Gynecologic Oncological Pelvic/Abdominal Surgery
Recruiting
Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Gynecologic Surgery
ERAS, Gynecologic Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ala S Haddadin, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin in people with Gynecologic Oncological Pelvic/Abdominal Surgery, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in incidence of deep vein thrombosis. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00259662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2016.