Cardiac ArrestPhase 3NCT04845607
Prophylactic Amiodarone for Shockable Cardiac Arrest
A Phase 3 study testing Amiodarone Injection in people with Cardiac Arrest and Ventricular Arrythmia, run by Won Young Kim at 1 site in South Korea.
Trial summary
The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Ventricular Arrythmia
- What is being tested?
- Amiodarone Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2021to 28 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER
Who cannot join
- age < 18 yr
- pregnancy
- non cardiac caused arrest such as hanging
- previous amiodarone continuous infusion before radomization
- sustained ventricular arrhythmia recurrence after ROSC
- extracorporeal membrane oxygenation
- contra indication for amiodarone
- disagree with this research
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Won Young Kim, MD,PhD, +82-2-3010-3350, wonpia73@naver.com
About this study
Official title: Prophylactic Amiodarone for Shockable Cardiac Arrest During Targeted Post Cardiac Arrest Care: Multi-center, Open Labelled Randomized Controlled Trial
The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR.
Read the detailed description
Patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. Especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during CPR, then they are at high risk of developing shockable re-arrest.
However until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care.
Amiodarone is class III anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during CPR.
In this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.
- Conditions
- Cardiac Arrest, Ventricular Arrythmia
- Being tested
- Amiodarone Injection
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amiodarone InjectionDrug
Amiodarone continuous infusion during 24 hours from return of spontaneous circulation.
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic amiodarone | Experimental | Not described Receives: Drug: Amiodarone Injection |
| Conventional management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with re-arrest by shockable rhythm
No recurrence of ventricular fibrillation or pulseless ventricular tachycardia
Measured: 5 days from return of spontaneous circulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 Apr 2021
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Won Young Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Won Young Kim, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845607
- Sponsor's protocol ID
- PASCA trial
- Status last verified
- Jun 2021
- First submitted
- 11 Apr 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Amiodarone for Shockable Cardiac Arrest During Targeted Post Cardiac Arrest Care: Multi-center, Open Labelled Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04845607
- Acronym / sponsor ID
- PASCA trial
- Conditions
- Cardiac Arrest, Ventricular Arrythmia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Won Young KimUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 15 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm in patients who treated with targeted temperature management after return of spontaneous circulation from cardiac arrest which had been shockable rhythm during CPR.
Detailed description
Patients with cardiac arrest are in high risk of re-arrest during post cardiac arrest care due to vulnerable heart state electrically and hemodynamically. Especially if patients who had experienced shockable rhythms such as ventricular fibrillation or pulseless ventricular tachycardia during CPR, then they are at high risk of developing shockable re-arrest.
However until now there has not been any evidence of prophylactic anti arrhythmic drug effect during post cardiac arrest care.
Amiodarone is class III anti arrhythmic drug which has been used for conversion of ventricular arrhythmia during CPR.
In this study we want to determine whether the prophylactic amiodarone can prevent re-arrest with ventricular shockable rhythm or not.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylactic amiodarone | Experimental | Drug: Amiodarone Injection |
| Conventional management | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non traumatic cardiac arrest patients who had VF or pVT during CPR in ER
Key exclusion criteria (8 listed)
- age < 18 yr
- pregnancy
- non cardiac caused arrest such as hanging
- previous amiodarone continuous infusion before radomization
- sustained ventricular arrhythmia recurrence after ROSC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amiodarone InjectionAmiodarone continuous infusion during 24 hours from return of spontaneous circulation. | Drug | Prophylactic amiodarone |
Primary outcome
Number of patients with re-arrest by shockable rhythm
Time frame: 5 days from return of spontaneous circulation
No recurrence of ventricular fibrillation or pulseless ventricular tachycardia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amiodarone Injection in people with Cardiac Arrest and Ventricular Arrythmia, run by Won Young Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with re-arrest by shockable rhythm (time frame: 5 days from return of spontaneous circulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021; AzTrials last refreshed its copy on 30 Oct 2026.