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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: K201 Injection

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel
  • Beer Sheva, Israel
  • Haifa, Israel
  • Holon, Israel
  • Jerusalem, Israel
  • Nazareth, Israel
  • Safed, Israel
• Russian Federation
  • Moscow, Russian Federation
  • St Petersburg, Russian Federation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: K201 Injection; single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Restoration of sinus rhythm	24hrs

Collaborators and Investigators

• Sponsor: Sequel Pharmaceuticals, Inc
• Investigators: Principal Investigator: Sergey Pavlovich Golitsyn, Prof., Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology; Principal Investigator: Amos Katz, Prof., Barzilai Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 18, 2008
• First Submitted That Met QC Criteria: February 20, 2008
• First Posted (Estimate): February 29, 2008

Study Record Updates

• Last Update Posted (Estimate): January 8, 2010
• Last Update Submitted That Met QC Criteria: January 7, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CJI-201