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Clinical Trials: Overview01:11

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Related Experiment Video

Updated: Feb 7, 2026

A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
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Ranolazine in High-Risk Patients With Implanted Cardioverter-Defibrillators: The RAID Trial.

Wojciech Zareba1, James P Daubert2, Christopher A Beck3

  • 1Department of Medicine, University of Rochester Medical Center, Rochester, New York.

Journal of the American College of Cardiology
|August 4, 2018
PubMed
Summary

Ranolazine did not significantly reduce the primary endpoint of ventricular tachycardia (VT), ventricular fibrillation (VF), or death in high-risk implantable cardioverter-defibrillator (ICD) patients. However, it showed a significant reduction in recurrent VT/VF requiring ICD therapy.

Keywords:
implantable cardioverter-defibrillatorranolazineventricular fibrillationventricular tachycardia

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Area of Science:

  • Cardiology
  • Electrophysiology
  • Pharmacology

Background:

  • Ventricular tachycardia (VT) and ventricular fibrillation (VF) pose significant challenges for patients with implantable cardioverter-defibrillators (ICDs).
  • Identifying effective pharmacological interventions to manage these arrhythmias in ICD patients is crucial for improving outcomes.

Purpose of the Study:

  • To evaluate the efficacy of ranolazine in reducing the incidence of VT, VF, or death in high-risk patients with ICDs.
  • To assess the impact of ranolazine on secondary endpoints, including ICD shocks and recurrent ventricular arrhythmias.

Main Methods:

  • A double-blind, placebo-controlled trial randomized 1,012 high-risk ICD patients with cardiomyopathy to receive either 1,000 mg of ranolazine twice daily or a placebo.
  • The primary endpoint was the first occurrence of VT/VF requiring appropriate ICD therapy or death.
  • Secondary endpoints included ICD shocks, recurrent VT/VF, and other clinical outcomes.

Main Results:

  • Ranolazine did not significantly reduce the primary endpoint (VT, VF, or death) compared to placebo (HR 0.84, p=0.117).
  • The study was underpowered to detect a significant difference in the primary endpoint.
  • Ranolazine was associated with a marginally significant reduction in recurrent VT or VF requiring ICD therapy (HR 0.70, p=0.028).

Conclusions:

  • Ranolazine did not significantly decrease the incidence of the first VT, VF, or death in high-risk ICD patients.
  • Ranolazine administration showed a significant reduction in recurrent VT or VF requiring ICD therapy, without increasing mortality.
  • Further studies are needed to confirm these findings and explore the role of ranolazine in specific ICD patient populations.