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Antiarrhythmic Agent
Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia (ALPS Trial)
Phase 3
Waitlist Available
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients will be followed from the time of the cardiac arrest until death, hospital discharge, or december 31, 2015, whichever occurs first.
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Pivotal Trial
Summary
The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (Nexterone-PM101) compared to placebo.
Eligible Conditions
- Heart Attack
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ patients will be followed from the time of the cardiac arrest until death, hospital discharge, or december 31, 2015, whichever occurs first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients will be followed from the time of the cardiac arrest until death, hospital discharge, or december 31, 2015, whichever occurs first.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Who Survive From the Time of Cardiac Arrest to Hospital Discharge
Secondary study objectives
Number of Participants Scoring at or Below a 3 on the MRS Scale
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: AmiodaroneActive Control1 Intervention
Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.
Group II: LidocaineActive Control1 Intervention
IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.
Group III: Normal salinePlacebo Group1 Intervention
IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.
Find a Location
Who is running the clinical trial?
Heart and Stroke Foundation of CanadaOTHER
130 Previous Clinical Trials
69,767 Total Patients Enrolled
Defence Research and Development CanadaIndustry Sponsor
13 Previous Clinical Trials
39,965 Total Patients Enrolled
American Heart AssociationOTHER
346 Previous Clinical Trials
4,968,163 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
291 Previous Clinical Trials
243,154 Total Patients Enrolled
University of WashingtonLead Sponsor
1,831 Previous Clinical Trials
1,904,545 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,944 Previous Clinical Trials
47,796,805 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,394 Previous Clinical Trials
26,524,834 Total Patients Enrolled
Myron Weisfeldt, MDStudy ChairJohns Hopkins University