ATRIAL FIBRILLATION (AF) FOLLOWING CORONARY ARTERY BY-PASS GRAFT (CABG)SURGERY. MedDRA version: 8.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Conditions
Interventions
Trade Name: Omacor
Product Name: OMACOR
Pharmaceutical Form: Capsule*
Concentration unit: IU/g international unit(s)/gram
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the
Sponsors
South Manchester University NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AL PATIENTS UNDER GOING ISOLATED CORONARY ARTERY BY-PASS SURGERY WHO ARE NOT KNOWN TO HAVE PRE- EXISTING ATRIAL FIBRILLATION AND ARE NOT TAKING ANY REGULAR ANTI-ARRYTHMIC DRUGS. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: PATIENTS WHO HAVE CONCOMMITANT VALVE SURGERY, PATIENTS ON ANTI-ARRYTHMIC DRUGS, PATIENTS WHO ARE KNOWN TO HAVE PRE-EXISTING ATRIAL FIBRILLATION.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: TO EVALUATE THE LIKELY BENEFICIAL EFFECT OF OMACOR ( OMEGA 3 FATTY ACIDS) SUPPLEMENT ON THE INCIDENCE OF ATRIAL FIBRILLATION FOLLOWING CORONARY ARTERY BY-PASS GRAFT (CABG) SURGERY.;Secondary Objective: TO ELUCIDATE THE MECHANISM OF ANTI-ARRYTHMIC ACTION OF OMACOR.;Primary end point(s): ATRIAL FIBRILLATION AFTER CABG. | — |
Countries
United Kingdom
Outcome results
None listed