Trial · NCT00970489

Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation

NCT00970489, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2017-04-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation. Trials, record NCT00970489. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00970489

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation
NCT number: NCT00970489
Status: Completed
Phases: Phase 3
Enrollment: 1,516 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Atrial Fibrillation
Interventions: Omega -3 fatty acids, Placebo
First posted: 2009-09-02
Last updated: 2017-04-10
Results first posted: 2017-04-10
Limitations and caveats: Best-practice guidelines for preventing post-op atrial fibrillation were recommended to Centers. The duration prior to surgery may have been too short to be effective; or the dose of n-3 PUFA too low to produce benefit

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Any First Post-op Atrial Fibrillation or Flutter (AF)	up to 10 days post-surgery or discharge, whichever sooner	Primary: Occurrence of post-CS AF (atrial fibrillation or flutter) of at least 30 seconds duration and confirmed by rhythm strip or 12-lead ECG. This will include definite AF and probable AF (SVT likely to be AF depending on rate and other characteristics).
Secondary	Post-op Af	up to 10 days post-surgery or discharge, whichever sooner	Secondary AF endpoints included post-op AF that was sustained (\>1 hour), symptomatic, or treated with pharmacological or electrical cardioversion; post-op AF excluding atrial flutter; time to first post-op AF; and the number of post-op AF episodes per patient. OPERA also evaluated the total number of in-hospital days in which any post-op AF, including sustained post-op AF, was present; and the proportion of in-hospital days free of any post-op AF. All potential episodes of post-op AF and other tachyarrhythmias were reviewed and adjudicated by a centralized Events Committee of cardiac electrophysiologists. Additional endpoints included resource utilization, major adverse cardiovascular events (MACE), arterial thromboembolism, and 30-day mortality.
Secondary	Other Arrhythmias	up to 10 days post-surgery or discharge, whichever sooner	* The first 3 suspected episodes of atrial fibrillation or flutter of at least 30 sec duration following randomization were documented, including the following information: * Printed or digital rhythm strip and/or 12-lead ECG. * Recording of time of onset and time of cessation. * Additional documentation of temporally associated signs of symptoms, such as new or worsening chest pain, shortness of breath, or lightheadedness; drop in blood pressure requiring escalation of fluid or pressor treatment; or need for electrical or pharmacologic cardioversion. * The first suspected episode of each of other supraventricular or unknown narrow-complex tachycardia of at least 30 sec duration following randomization was also documented.
Secondary	Other Endpoints	up to 10 days post-surgery or discharge, whichever sooner	1. Number of days in the ICU, of telemetry monitoring, and of total hospital stay. 2. Non-AF arrhythmias of at least 30 sec duration, including non-AF-SVT, ventricular tachycardia (VT), and ventricular flutter (VF), assessed and adjudicated by the Events Committee. 3. MACE: Combined total mortality, myocardial infarction, and stroke. 4. Bleeding, assessed by (a) chest tube output in the 24 hour period following surgery and (b) total number of packed red blood cell (RBC) transfusions from enrollment to end of treatment (hospital discharge or post-op day 10). 5. Significant adverse events: Discontinuation of study treatment, at the discretion of the treating physicians, for suspected significant allergic reaction, severe gastrointestinal intolerance, significant bleeding, or other side effects requiring discontinuation. 6. Thirty-day mortality assessed 7. One-year mortality assessed

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Any First Post-op Atrial Fibrillation or Flutter (AF)	up to 10 days post-surgery or discharge, whichever sooner	Participants	NUMBER
SECONDARY	Post-op Af	up to 10 days post-surgery or discharge, whichever sooner	Participants	NUMBER
SECONDARY	Other Arrhythmias	up to 10 days post-surgery or discharge, whichever sooner	Participants	NUMBER
SECONDARY	Other Endpoints	up to 10 days post-surgery or discharge, whichever sooner	Participants	NUMBER

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Any First Post-op Atrial Fibrillation or Flutter (AF)	Olive Oil Capsule		233	Participants
Any First Post-op Atrial Fibrillation or Flutter (AF)	Omega-3 Fatty Acid Capsules		227	Participants
Post-op Af	Olive Oil Capsule	Sustained, symptomatic, or treated post-op AF	231	Participants
Post-op Af	Omega-3 Fatty Acid Capsules	Sustained, symptomatic, or treated post-op AF	224	Participants
Post-op Af	Olive Oil Capsule	Post-op AF excluding flutter	220	Participants
Post-op Af	Omega-3 Fatty Acid Capsules	Post-op AF excluding flutter	217	Participants
Other Arrhythmias	Olive Oil Capsule	Other supraventricular tachycardia	6	Participants
Other Arrhythmias	Omega-3 Fatty Acid Capsules	Other supraventricular tachycardia	11	Participants
Other Arrhythmias	Olive Oil Capsule	Ventricular tachycardia or fibrillation	9	Participants
Other Arrhythmias	Omega-3 Fatty Acid Capsules	Ventricular tachycardia or fibrillation	5	Participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Olive Oil Capsule	758
Overall Study	STARTED	Omega-3 Fatty Acid Capsules	758
Overall Study	COMPLETED	Olive Oil Capsule	704
Overall Study	COMPLETED	Omega-3 Fatty Acid Capsules	717
Overall Study	NOT COMPLETED	Olive Oil Capsule	54
Overall Study	NOT COMPLETED	Omega-3 Fatty Acid Capsules	41

Source ClinicalTrials.gov

Adverse events52

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bone marrow or coagulation	Blood and lymphatic system disorders	Olive Oil Capsule	0	758	0
other	Bone marrow or coagulation	Blood and lymphatic system disorders	Omega-3 Fatty Acid Capsules	0	758	0
other	Bleeding	Blood and lymphatic system disorders	Olive Oil Capsule	7	758	7
other	Bleeding	Blood and lymphatic system disorders	Omega-3 Fatty Acid Capsules	2	758	2
other	Cardiac	Cardiac disorders	Olive Oil Capsule	3	758	3
other	Cardiac	Cardiac disorders	Omega-3 Fatty Acid Capsules	6	758	6
other	Constitutional symptoms	General disorders	Olive Oil Capsule	1	758	1
other	Constitutional symptoms	General disorders	Omega-3 Fatty Acid Capsules	0	758	0
other	Dermatology or musculoskeletal	Musculoskeletal and connective tissue disorders	Olive Oil Capsule	0	758	0
other	Dermatology or musculoskeletal	Musculoskeletal and connective tissue disorders	Omega-3 Fatty Acid Capsules	0	758	0

1 to 10 of 52Source ClinicalTrials.gov

See all 52 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Olive Oil Capsule
Total, all-cause mortality	Omega-3 Fatty Acid Capsules
Total, other adverse events	Olive Oil Capsule	20	758
Total, other adverse events	Omega-3 Fatty Acid Capsules	19	758
Total, serious adverse events	Olive Oil Capsule	147	758
Total, serious adverse events	Omega-3 Fatty Acid Capsules	136	758

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21742090	DERIVED	PubMed
23128104	DERIVED	PubMed
24145742	DERIVED	PubMed
25994442	DERIVED	PubMed
29546292	DERIVED	PubMed
30571332	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Olive Oil Capsule vs Omega-3 Fatty Acid Capsules: Any First Post-op Atrial Fibrillation or Flutter (AF)	Trial comparisons
Olive Oil Capsule vs Omega-3 Fatty Acid Capsules: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00970489

GET https://conductscience.org/api/trials/v1/NCT00970489/events?page=2

API reference For AI assistants