Trial Outcomes & Findings for Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049) (NCT NCT01370629)

NCT ID: NCT01370629

Last Updated: 2019-12-30

Results Overview

Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) \<90 mmHg, requiring treatment with vasopressors

• Recruitment status: COMPLETED
• Target enrollment: 2015 participants
• Primary outcome timeframe: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
• Results posted on: 2019-12-30

Participant Flow

Participant milestones

Measure	All Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Overall Study STARTED	2015
Overall Study COMPLETED	2009
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Normal Conditions of Use, Dosing, and Safety of Intravenous (IV) Administration of Vernakalant (MK-6621-049)

Baseline characteristics by cohort

Measure	All Participants n=2009 Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1024 Participants n=5 Participants
Age, Categorical >=65 years	985 Participants n=5 Participants
Sex: Female, Male Female	787 Participants n=5 Participants
Sex: Female, Male Male	1222 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	1931 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	5 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	65 Participants n=5 Participants
Region of Enrollment Austria	547 participants n=5 Participants
Region of Enrollment Sweden	493 participants n=5 Participants
Region of Enrollment Finland	256 participants n=5 Participants
Region of Enrollment Denmark	113 participants n=5 Participants
Region of Enrollment Germany	300 participants n=5 Participants
Region of Enrollment Spain	300 participants n=5 Participants

PRIMARY outcome

Timeframe: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion

Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) <90 mmHg, requiring treatment with vasopressors

Outcome measures

Measure	All Participants n=2009 Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Number of Participants Experiencing Significant Hypotension	2 Participants

PRIMARY outcome

Timeframe: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion

Outcome measures

Measure	All Participants n=2009 Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Number of Participants Experiencing Significant Ventricular Arrhythmia	1 Participants

PRIMARY outcome

Timeframe: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion

Outcome measures

Measure	All Participants n=2009 Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Number of Participants Experiencing Significant Atrial Flutter	2 Participants

PRIMARY outcome

Timeframe: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion

Outcome measures

Measure	All Participants n=2009 Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Number of Participants Experiencing Significant Bradycardia	15 Participants

SECONDARY outcome

Timeframe: Up to 90 minutes after the start (baseline) of first infusion of vernakalant

Outcome measures

Measure	All Participants n=1936 Participants Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute	1359 Participants

Adverse Events

All Participants

Serious events: 26 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Participants n=2009 participants at risk Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Cardiac disorders Significant hypotension	0.10% 2/2009 • Number of events 2 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders significant ventricular arrhythmia	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Significant bradycardia	0.75% 15/2009 • Number of events 15 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Significant atrial flutter with 1:1 conduction	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Supraventricular tachycardia	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Non-sustained ventricular tachycardia	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Non-sustained wide QRS complex tachycardia	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Angina pectoris	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Hypotension	0.10% 2/2009 • Number of events 2 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Cardiac disorders Pericardial effusion	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Eye disorders Visual disturbance	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Injury, poisoning and procedural complications Overdose	0.05% 1/2009 • Number of events 1 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section

Other adverse events

Measure	All Participants n=2009 participants at risk Participants treated with vernakalant IV in acute care and inpatient hospital settings Vernakalant: Prescribed at the discretion of the physician in accordance with their usual practice
Nervous system disorders Dysgeusia	1.7% 35/2009 • Number of events 35 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section
Respiratory, thoracic and mediastinal disorders Sneezing	1.3% 27/2009 • Number of events 27 • 24 hours after the last infusion of vernakalant IV or until discharge / end of medical encounter, whichever occurred earlier Health outcomes of interest (HOIs) were reported as defined in the study protocol section

Additional Information

Head of Clinical Development

Correvio International

Phone: +41 (0) 22 907 79 70

Email: info@correvio.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER