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

Study acronym: VARIANT ICD
StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Study sites: 25 to 26v11
  2. Primary completion date: Dec 2029 to Dec 2030
    • Study completion date: Jun 2030 to Jun 2031
    • Site details revised at 18 of 25 sites
    v10
  3. Study description expanded, about 64 wordsv9
  4. Primary completion date: Dec 2022 to Dec 2029
    • Study completion date: Jun 2023 to Jun 2030
    v8
  5. Study sites: 23 to 25v7
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  1. Secondary endpoints: 8 to 9
    • Site details revised at 6 of 23 sites
    v6
  2. Re-verified, no change to tracked fieldsv5
  3. Study sites: 22 to 23v4
  4. Study sites: 21 to 22v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 2016 to Nov 29, 2016
    • Study sites: 1 to 21
    • Eligibility criteria shortened, about 1 word
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02845531
Lead Sponsor Kee-joon Choi
Collaborators: CardioVascular Research Foundation, Korea
Conditions
(from sponsor)		 Angina Pectoris, Variant, Sudden Cardiac Death
Related terms Angina Pectoris, Variant, Death, Sudden, Cardiac
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov