NCT00375518

Brief Summary

This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce problems after surgery such as arrhythmias or lung inflammation which may be serious. This study will be randomized and double blind, meaning that patients are placed in groups purely by chance, like flipping a coin. Neither the patient or doctor will know which group the patient is in.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 22, 2016

Completed
Last Updated

January 6, 2021

Status Verified

December 1, 2020

Enrollment Period

7.8 years

First QC Date

September 11, 2006

Results QC Date

December 16, 2015

Last Update Submit

December 9, 2020

Conditions

Thoracic Surgery

Keywords

Thoracic SurgeryCardiopulmonary complicationsAtorvastatin

Outcome Measures

Primary Outcomes (1)

  • Determine the Postoperative Complications Found in Each Group

    To determine whether one week of preventive therapy with atorvastatin prior to surgery and one week after surgery reduced the composite rate of cardiovascular morbidity when compared to placebo.

    one week (minimum of 5 days) before surgery and continued for one week (minimum of 5 days) after surgery

Study Arms (2)

1

ACTIVE COMPARATOR

Atorvastatin

Drug: Atorvastatin

2

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

AtorvastatinDRUG

Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.

1
PlaceboDRUG

Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients ≥ 18 yr. scheduled for anatomic lung resection (segmentectomy, lingulectomy, possible or definite lobectomy, bilobectomy, pneumonectomy or extrapleural pneumonectomy) with or without chest wall resection or limited resection
  • Patients with regular cardiac rhythm
  • Patients able to take oral capsules
  • Patients capable of providing written, informed consent
  • Patients without known hepatic or kidney disease

You may not qualify if:

  • Patients already taking any statin, gemfibrozil (Lopid), or ezetimibe (Zetia)
  • Hypersensitivity to atorvastatin
  • Chronic atrial fibrillation
  • Patients already taking class Ic or III antiarrhythmic drugs
  • Known pregnancy a urine pregnancy test will be given to women of childbearing age
  • Known history of active hepatic disease or known hepatic insufficiency
  • Known history of active kidney disease or insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center 1275 York Avenue

New York, New York, 10021, United States

Location

Related Publications (1)

  • Amar D, Park B, Zhang H, Shi W, Fleisher M, Thaler HT, Rusch VW. Beneficial effects of perioperative statins for major pulmonary resection. J Thorac Cardiovasc Surg. 2015 Jun;149(6):1532-8. doi: 10.1016/j.jtcvs.2014.12.016. Epub 2014 Dec 18.

    PMID: 25623903DERIVED

Related Links

MeSH Terms

Interventions

Atorvastatin

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Dr. David Amar
Organization
Memorial Sloan Kettering Cancer Center
amard@mskcc.org
212-639-6798

Study Officials

  • David Amar, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 6, 2021

Results First Posted

January 22, 2016

Record last verified: 2020-12

Locations

US(1)