Contact information
Type
Scientific
Primary contact
Dr Stevie Jorge Horbach
ORCID ID
Contact details
Rua Sinimbu
2019
Apto. 1503
Caxias do Sul - Rio Grande do Sul
95020001
Brazil
+55 (0)11 76738082/05430254181
steviehorbach@yahoo.com.br
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
NAFARM
Study hypothesis
Postoperative atrial fibrillation occurs in 25 to 40 percent of patients undergoing Coronary Artery Bypass Graft (CABG) surgery. Although prophylactic therapy with beta-adrenergic blockers and amiodarone reduces the incidence of postoperative atrial fibrillation, this arrhythmia remains an important cause of increased hospital mortality, stays and expenses after CABG surgery. There is mounting evidence to support the influence of inflammation (increased levels of C-reactive protein, interleukin-6, tumour necrosis factor, atrial myocarditis and pericarditis) in the pathogenesis of postoperative atrial fibrillation. Naproxen is a nonsteroidal anti-inflammatory drug that has a role in inflammation and can have an effect on postoperative atrial fibrillation.
Hypothesis: Naproxen reduces the incidence of postoperative atrial fibrillation after coronary artery bypass graft surgery.
Ethics approval
Approved by the Pontificia Catholic University of Rio Grande do Sul (Pontificia Universidade Catolica do Rio Grande do Sul) Human Research Committee and Brazilian National Ethics Committee on Research (CONEP) on 09/01/2004 (ref: 0232.0.002.000-04)
Study design
Single-centre, double-blind, randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Atrial fibrillation
Intervention
The patients are interviewed on the day of their initial evaluations in the cardiac surgery unit at the Sao Lucas da PUCRS Hospital. They are randomly assigned in a double-blind fashion to begin oral therapy immediately after their CABG surgery. Each patient is admitted to an intensive care unit and is monitored on Marquette HelligeVicom-SM ICU monitor. Naproxen/placebo are administered at a dosage of 275 mg two times a day for five days. The placebo tablets are identical in appearance to the naproxen tablets. The patients receive a nasogastric tube while mechanical ventilation to receive the study medication. If the patient has risk factors for gastrointestinal bleeding (age above 60 years, history of peptic ulcer disease, use of glucocorticoids or oral anticoagulant) he receives concomitant Omeprazole 20 mg, one tablet orally each day. The investigator evaluates the patients daily. After discharge from the intensive care unit the patient is monitored with 12-lead electrocardiogram and by the investigator for symptoms.
Intervention type
Drug
Phase
Not Specified
Drug names
Naproxen
Primary outcome measures
The incidence of postoperative atrial fibrillation, determined within 5 days of the patient's coronary artery bypass graft surgery. Atrial fibrillation is counted if it persists for more than three minutes or the patient develops hemodynamic instability.
Secondary outcome measures
Overall length of hospital stay and length of stay at the intensive care unit.
Overall trial start date
22/11/2004
Overall trial end date
12/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Informed consent
2. Older than 18 years
3. Scheduled for exclusive coronary artery bypass graft surgery requiring cardiopulmonary bypass
4. Normal sinus rhythm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
Exclusion criteria amended as of 16/11/2007:
1. Patients who are allergic to naproxen or other nonsteroidal anti-inflammatory drugs
2. Patients who are participating in another investigational trial
3. Pregnant women
4. Renal failure
5. History of gastrointestinal bleeding
6. Chronic liver disease
7. Thrombocytopenia (platelets below 50.000/mm^3)
8. Preoperative use of glucocorticoids
9. Previous diagnosis of atrial fibrillation
Exclusion criteria provided at time of registration:
1. Patients who are allergic to naproxen or other nonsteroidal anti-inflammatory drugs
2. Patients who are participating in another investigational trial
3. Pregnant women
4. Renal failure
5. History of gastrointestinal bleeding
6. Chronic hepatitis
7. Thrombocytopenia (platelets below 50.000/mm^3)
Recruitment start date
22/11/2004
Recruitment end date
12/04/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Rua Sinimbu, 2019
Caxias do Sul - Rio Grande do Sul
95020001
Brazil
Sponsor information
Organisation
Sao Lucas da PUCRS Hospital and the Sao Paulo Federal University (Brazil)
Sponsor details
Ipiranga Avenue
6690
Jardim Botânico
Cardiology Department
Porto Alegre/RS
90610-000
Brazil
+55 51 3320 5120
cardiologia-hsl@pucrs.br
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Internally funded by the Cardiology Unit of Sao Lucas da PUCRS Hospital (Brazil)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary