Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01464476

Acronym

SHIELD-2

Enrollment

240

Registered

2011-11-03

Start date

2011-11-30

Completion date

2013-06-30

Last updated

2013-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases, Implantable Cardioverter Defibrillator

Brief summary

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)

Interventions

DRUGAzimilide Dihydrochloride

Azimilide 75 mg. Once daily, oral administration

DRUGPlacebo

Dose-matched placebo. Once daily, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy. * Have a left ventricular ejection fraction \<= 0.40

Exclusion criteria

* Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization; * Have unstable angina pectoris or a myocardial infarction within 30 days of randomization; * Have a history of Torsade de Pointes or heart transplantation * Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening; * Are currently taking systemic Class I or other Class III antiarrhythmic drugs * Are currently taking systemic drugs that prolong the QT interval * If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study

Design outcomes

Primary

Measure	Time frame	Description
Time to first cardiovascular event	365 days	Time to first unplanned cardiovascular hospitalization, unplanned cardiovascular emergency department visit, or cardiovascular death in patients with an Implantable Cardioverter Defibrillator (ICD)

Secondary

Measure	Time frame	Description
Time to first all-cause shock by the ICD	365 days	Time to first all-cause shock initiated by the Implantable Cardioverter Defibrillator
Time to first unplanned physician-office visit.	365 days	Time to the first unplanned physician-office visit.

Countries

Belgium, Canada, Czechia, Denmark, France, Germany, Israel, Italy, Netherlands, Poland, Spain, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026