Naproxen as prophylaxis against atrial fibrillation after coronary artery bypass graft surgery
| ISRCTN | ISRCTN10318446 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10318446 |
| Secondary identifying numbers | N/A |
- Submission date
- 25/09/2007
- Registration date
- 10/10/2007
- Last edited
- 10/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Stevie Jorge Horbach
Scientific
Scientific
Rua Sinimbu, 2019
Apto. 1503
Caxias do Sul - Rio Grande do Sul
95020001
Brazil
| Phone | +55 (0)11 76738082/05430254181 |
|---|---|
| steviehorbach@yahoo.com.br |
Study information
| Study design | Single-centre, double-blind, randomized controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Naproxen as prophylaxis against atrial fibrillation after coronary artery bypass graft surgery |
| Study 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(s) | 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) |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Naproxen |
| Primary outcome measure | 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 study start date | 22/11/2004 |
| Overall study end date | 12/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 161 |
| 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 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
Study participating centre
Rua Sinimbu, 2019
Caxias do Sul - Rio Grande do Sul
95020001
Brazil
95020001
Brazil
Sponsor information
Sao Lucas da PUCRS Hospital and the Sao Paulo Federal University (Brazil)
Hospital/treatment centre
Hospital/treatment centre
Ipiranga Avenue, 6690
Jardim Botânico
Cardiology Department
Porto Alegre/RS
90610-000
Brazil
| Phone | +55 51 3320 5120 |
|---|---|
| cardiologia-hsl@pucrs.br | |
| Website | http://www.hospitalsaolucas.pucrs.br |
"ROR" |
https://ror.org/0353n6963 |
Funders
Funder type
Hospital/treatment centre
Internally funded by the Cardiology Unit of Sao Lucas da PUCRS Hospital (Brazil)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/11/2011 | 10/06/2021 | Yes | No |
Editorial Notes
10/06/2021: Publication reference and total final enrolment added.
