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Angina Pectoris, VariantPhase 4VARIANT ICDNCT02845531

Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death

A Phase 4 study testing Implantable Cardioverter Defibrillator and Optimal Medical Therapy in people with Angina Pectoris, Variant and Sudden Cardiac Death, run by Kee-joon Choi at 26 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
26 sitesSouth Korea
Study dates
29 Nov 2016to Jun 2031
Phase
Phase 4
Are there results?
Not yet: the study is under way

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

  • Age 18 years or older
  • Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia
  • Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography

Who cannot join

  • Significant (>50%) coronary artery stenosis on coronary angiography
  • Organic heart disease known to be associated with sudden cardiac arrest.
  • Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction < 35%)
  • Presence of LV akinesia or aneurysm
  • Hypertrophic cardiomyopathy
  • Arrhythmogenic right ventricular dysplasia
Show all 15Show fewer
  • Chronic Heart Failure New York Heart Association functional class III or IV
  • prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
  • Prior catheter ablation for ventricular arrhythmia
  • Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
  • Prior pacemaker or Implantable Cardioverter Defibrillator
  • 2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
  • Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3)
  • Life expectancy <2 years
  • Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kee-joon Choi, MD contact

kjchoi@amc.seoul.kr

26 sites in 1 country

South Korea26 sites, 18 recruiting

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si

    Hyung-o Choi, MD

    Hyung-o Choi, MD

    Recruiting

  • Busan National University Yangsan Hospital

    Busan

    Ki-won Hwang, MD

    Ki-won Hwang, MD

    Recruiting

  • Busan University Hospital

    Busan

    Active, not recruiting

  • Dong-A Medical Center

    Busan

    Jong-sung Park, MD

    Jong-sung Park, MD

    Recruiting

  • Soon Chun Hyang University Hospital Cheonan

    Cheonan

    Active, not recruiting

  • Keimyung University Dongsan Medical Center

    Daegu

    Jongmin Hwang, MD

    Jongmin Hwang, MD

    Recruiting

  • Chungnam National University Hospital

    Daejeon

    Jae-Hwan Lee, MD

    Jae-Hwan Lee, MD

    Recruiting

  • Gangneung Asan Hospital

    Gangneung

    Withdrawn

  • Chonnam National University Hospital

    Gwangju

    Hyung-wook Park, MD

    Hyung-wook Park, MD

    Recruiting

  • Wonkwang University Hospital

    Iksan

    Withdrawn

  • Inje University Ilsan Paik Hospital

    Ilsan

    Hyeon jeong Oh, MD

    Hyeon jeong Oh, MD

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Seung-Hwan Han, MDD

    Seung-Hwan Han, MD

    Recruiting

  • Chonbuk National University Hospital

    Jeonju

    Kyung-seok Lee, MD

    Kyung-seok Lee, MD

    Recruiting

  • Chungnam National University Sejong Hospital

    Sejong

    Minsu Kim, MD

    Minsu Kim, MD

    Recruiting

  • Seoul university Bundang hospital

    Seongnam

    Il-young Oh, MD

    Il-young Oh, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Kee-joon Choi, MD

    Kee-joon Choi, MD

    Recruiting

  • Ewha Womans University Mokdong Hospital

    Seoul

    Jun-Beom Park, MD

    Jun-Beom Park, MD

    Recruiting

  • Kangdong KyungHee University hospital

    Seoul

    Eun-sun Jin, MD

    Eun-sun Jin, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul

    Young-hoon Kim, MD

    Young-hoon Kim, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Terminated

  • Seoul National University Boramae Medical Center

    Seoul

    Woo-hyun Lim, MD

    Woo-hyun Lim, MD

    Recruiting

  • Seoul National University Hospital

    Seoul

    Se-il Oh, MD

    Se-il Oh, MD

    Recruiting

  • Severance Hospital

    Seoul

    Withdrawn

  • The Catholic Univ. of Korea, Seoul St. Mary's Hospital

    Seoul

    Active, not recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul

    Withdrawn

  • Ajou University Hospital

    Suwon

    Kyo-seung Hwang, MD

    Kyo-seung Hwang, MD

    Recruiting

Other trials in South Korea

About this study

The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.

Read the detailed description

All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Being tested
Implantable Cardioverter Defibrillator, Optimal Medical Therapy
Keywords
Variant angina, Aborted sudden cardiac death, Implantable Cardioverter Defibrillator, Optimal Medical Therapy, ICD
Medical subject headings
Angina Pectoris, Variant, Death, Sudden, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable Cardioverter DefibrillatorDevice

    Implantable Cardioverter Defibrillator and Optimal Medical Therapy

  • Optimal Medical TherapyDrug

Study groups in NCT02845531
Study groupRoleWhat they receive
ICD implantation and optimal medical therapyExperimentalNot described
Receives: Device: Implantable Cardioverter Defibrillator
optimal medical therapyActive comparatorNot described
Receives: Drug: Optimal Medical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death from any cause

    Measured: 5 years

Secondary outcomes (9)

  1. Event rate of Cardiac death

    Measured: 5 years

  2. Event rate of Death from arrhythmia

    Measured: 5 years

  3. Event rate of Cardiac arrest

    Measured: 5 years

  4. Event rate of Recurrence of ventricular tachyarrhythmia

    Measured: 5 years

  5. Event rate of Hospitalization

    Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia

    Measured: 5 years

  6. Event rate of Appropriate ICD therapies

    Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously

    Measured: 5 years

  7. Event rate of Inappropriate ICD therapies

    Measured: 5 years

  8. Event rate of Major device-related complications

    Measured: 5 years

  9. Event rate of Stroke

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study start29 Nov 2016
  3. Primary completionDec 2030 (estimated)
  4. Study completionJun 2031 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02845531
Sponsor's protocol ID
AMCCV2016-15
Acronym
VARIANT ICD
Status last verified
Jun 2026
First submitted
24 Jul 2016
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Implantable Cardioverter Defibrillator and Optimal Medical Therapy in people with Angina Pectoris, Variant and Sudden Cardiac Death, run by Kee-joon Choi at 26 sites 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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kee-joon Choi, MD (kjchoi@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death from any cause (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02845531.

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 25 Jun 2026.

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