Study of K201 Injection on Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation (RESTORATION)

Sequel Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atrial Fibrillation

Treatments: Drug: K201 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00626652

CJI-201

Details and patient eligibility

About

To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic atrial fibrillation
• Atrial fibrillation documented by ECG
• Adherence to local clinical standards or the ACC/AHA/ESC practice guidelines for atrial fibrillation regarding thrombo-embolic event prevention and treatment.

Exclusion criteria

• Systolic blood pressure <100 mmHg
• Heart rate <50 bpm
• Temperature >38°C
• QT or QTcB >440 ms
• QRS >140 ms
• Paced atrial or ventricular rhythm on ECG
• Serum potassium <3.5 meq/L
• History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
• History of amiodarone in last 6 months.
• Clinical evidence of acute coronary syndrome
• Acute pulmonary edema or embolism
• Hyperthyroidism
• Acute pericarditis
• History of failed electrical cardioversion at any time
• History of torsades des pointes
• History of familial long QT interval syndrome
• History of ventricular tachycardia requiring drug or device therapy
• History of NYHA Heart Failure Class 3 or 4.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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153 participants in 1 patient group

1

Experimental group

Treatment:

Drug: K201 Injection