Condition category
Circulatory System
Date applied
25/09/2007
Date assigned
10/10/2007
Last edited
16/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.hospitalsaolucas.pucrs.br

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

Publication citations

Additional files

Editorial Notes