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Naproxen as prophylaxis against atrial fibrillation after coronary artery bypass graft surgery

Naproxen as prophylaxis against atrial fibrillation after coronary artery bypass graft surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10318446
Enrollment
200
Registered
2007-10-10
Start date
2004-11-22
Completion date
Unknown
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System Atrial fibrillation

Interventions

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

Sponsors

Sao Lucas da PUCRS Hospital and the Sao Paulo Federal University (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Overall length of hospital stay and length of stay at the intensive care unit.

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026