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A randomized, controlled clinical study evaluating the effectiveness and safety of nifekaline hydrochloride and amiodarone hydrochloride in the treatment of new-onset atrial fibrillation or atrial flutter after cardiac surgery

A randomized, controlled clinical study evaluating the effectiveness and safety of nifekaline hydrochloride and amiodarone hydrochloride in the treatment of new-onset atrial fibrillation or atrial flutter after cardiac surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033860
Enrollment
Unknown
Registered
2020-06-14
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

New-onset atrial fibrillation or atrial flutter after cardiac surgery

Interventions

Sponsors

Department of Cardiovascular Surgery, Shandong Provincial Hospital affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Aged >=18 years; 45kg <= body weight <= 100kg; 3h <= new atrial fibrillation/atrial flutter after cardiac surgery <=48h.

Exclusion criteria

Exclusion criteria: 1. Anticoagulant contraindications; 2. Electroversion contraindications; 3. Hemodynamic instability; 4. Acute coronary syndrome; 5. QRS greater than 0.14 seconds or ventricular rate less than 50 times/min, and withou pacemaker; 6. Usage within 24 hours of class I or class III antiarrhythmic drugs; 7. Female patients with QTc interval greater than 0.480s and male patients greater than 0.470s; 8. Patients with NYHA cardiac function grade IV; 9. Diastolic blood pressure less than 60mmHg or systolic blood pressure less than 95mmHg; 10. Blood potassium < 3.5mmol/L; Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Cardioversion of atrial fibrillation/atrial flutter;

Secondary

MeasureTime frame
adverse event;

Countries

China

Contacts

Public ContactHaizhou Zhang

Department of Cardiovascular Surgery, Shandong Provincial Hospital affiliated to Shandong First Medical University

zhz_doctor@163.com+86 15168889333

Outcome results

None listed

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