Clinical observation for nifekalan hydrochloride injection and amiodarone hydrochloride injection in the treatment of acute coronary syndrome with atrial fibrillation

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900021156

Enrollment

Unknown

Registered

2019-01-30

Start date

2019-02-11

Completion date

Unknown

Last updated

2019-02-04

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

Conditions

Atrial fibrillation

Interventions

Experimental group:Nifekalan is administered

Control group:Amiodarone is administered

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged at least 18 years old male and female; 2. Acute coronary syndrome with new or paroxysmal atrial fibrillation who need to be transferred to sinus rhythm; 3. The hemodynamics is relatively stable, no need of electrocardioversion for the time being; 4. Duration of af attack <48 hours.

Exclusion criteria

Exclusion criteria: 1. Uncorrected QT interval > 440ms; 2. Patients with other advanced diseases; 3. The ventricular rate less than 50 beats/min, and the QRS interval greater than 140ms; 4. Previous history of TdP; 5. Patients with amiodarone contraindications; 6. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
ECG;	—

Secondary

Measure	Time frame
2 hours efficiency;2-4 hours efficiency;Average turnaround time;Average turnaround dosage;Changes in patients’ symptoms;	—

Countries

China

Contacts

Public ContactMulei Chen

Affiliated Beijing Chaoyang Hospital of Capital Medical University

cml68@sina.cn+86 13911995971

Outcome results

None listed

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