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
1 other identifier
interventional
153
2 countries
9
Brief Summary
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 atrial-fibrillation
Started Mar 2008
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2008
CompletedFirst Posted
Study publicly available on registry
February 29, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJanuary 8, 2010
January 1, 2010
1.8 years
February 18, 2008
January 7, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Restoration of sinus rhythm
24hrs
Study Arms (1)
1
EXPERIMENTALInterventions
single intravenous infusion of Dose 1 - 10 or placebo (saline) or single oral capsule Dose A or placebo capsule
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Ashkelon, Israel
Unknown Facility
Beersheba, Israel
Unknown Facility
Haifa, Israel
Unknown Facility
Holon, Israel
Unknown Facility
Jerusalem, Israel
Unknown Facility
Nazareth, Israel
Unknown Facility
Safed, Israel
Unknown Facility
Moscow, Russia
Unknown Facility
Saint Petersburg, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 18, 2008
First Posted
February 29, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 8, 2010
Record last verified: 2010-01