Trial Outcomes & Findings for Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer (NCT NCT01259284)

Last Updated: 2012-08-07

Results Overview

New onset of sustained (15 min or \>) or clinically significant (requiring intervention) atrial fibrillation (AF) during first 4 days post surgery as defined by on American College of Cardiology and American Heart Association Physician Consortium.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

2 participants

Primary outcome timeframe

Baseline to 4 days post surgery

Results posted on

2012-08-07

Participant Flow

Recruitment Period: January 06, 2011 to July 29, 2011. All recruitment done at UT MD Anderson Cancer Center.

The study was terminated with only 2 participants enrolled. The inability to find participants was predominantly due to current or recent use of statins or fish oils.

Participant milestones

Participant milestones
Measure	Atorvastatin 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.	Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.	Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
Overall Study STARTED	2	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Atorvastatin 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.	Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.	Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
Overall Study Study Termination	2	0	0

Baseline Characteristics

Fish Oil Versus Statins Versus Placebos in Reducing Atrial Fibrillation in Patients Undergoing Thoracic Surgery for Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atorvastatin n=2 Participants 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.	Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.	Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.	Total n=2 Participants Total of all reporting groups
Age Continuous	69 years n=93 Participants	—	—	69 years n=483 Participants
Gender Female	2 participants n=93 Participants	—	—	2 participants n=483 Participants
Gender Male	0 participants n=93 Participants	—	—	0 participants n=483 Participants
Region of Enrollment United States	2 participants n=93 Participants	—	—	2 participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline to 4 days post surgery

Population: Analysis was to be per protocol. There is no analysis due to an inadequate number of enrolled participants in study which resulted in early termination.

Outcome measures

Outcome data not reported

Adverse Events

Atorvastatin

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Fish Oil Supplement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Atorvastatin n=2 participants at risk 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.	Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.	Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
Blood and lymphatic system disorders decreased hemoglobin	100.0% 2/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months

Other adverse events

Other adverse events
Measure	Atorvastatin n=2 participants at risk 1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.	Fish Oil Supplement 3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.	Placebo 4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
General disorders Pain in extremity	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months
Blood and lymphatic system disorders hypotension	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months
Cardiac disorders atrial fibrillation	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months
Gastrointestinal disorders nausea	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months
Respiratory, thoracic and mediastinal disorders dyspnea	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months
General disorders fatigue	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months
Gastrointestinal disorders anorexia	50.0% 1/2 • 9 Months	— 0/0 • 9 Months	— 0/0 • 9 Months

Additional Information

Ara Vaporciyan, MD, BS / Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place