Ranolazine for Improving Symptoms of Palpitations

Last updated: March 6, 2013
Sponsor: University of Roma La Sapienza
Overall Status: Trial Status Unknown

Phase

4

Condition

Thrombosis

Angina

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT01495520
671/2011/D
  • All Genders

Study Summary

Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations. Ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels. It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time. Aim of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptoms of palpitations

  • Angiographically-proven coronary artery disease

  • Stable conditions

  • No recent acute coronary syndromes

  • Able to understand and willing to sign the informed consent form

  • Symptomatic patients (palpitation) with stable angina pectoris already on therapy withbeta-blockers and/or calcium antagonists.

Exclusion

Exclusion Criteria:

  • Women of child bearing potential patients must demonstrate a negative pregnancy testperformed within 24 hours

  • Severe renal failure

  • Severe hepatic failure

Study Design

Total Participants: 100
Study Start date:
January 01, 2014
Estimated Completion Date:
December 31, 2016

Study Description

Background:

Patients with ischemic heart disease often report multiple symptoms, including angina and palpitations.

Ranolazine is a novel antianginal and antiischemic drug that reduces intracellular sodium and calcium accumulation during ischemia thus limiting ischemic injury. Furthermore, ranolazine has antiarrhythmic effects which are largely a result of the drug's effect on multiple ion channels.

It has previously been shown that treatment with ranolazine can reduce the frequency of supraventricular and ventricular tachycardia in the short term. In a subgroup analysis of the MERLIN-TIMI 36 trial, the continuous ECGs of 6,351 patients were analyzed. The results showed that, in comparison with placebo, treatment with ranolazine resulted in fewer episodes of ventricular tachycardia that lasted 8 beats or longer (5.3% versus 8.3%; P <0.001), and in fewer episodes of supraventricular tachycardia (44.7% versus 55%; P <0.001) and new-onset atrial fibrillation (1.7% versus 2.4%; P=0.08).

It remains unknown, however, whether the favorable effects of ranolazine on symptoms and arrhythmias are maintained over time.

Purpose:

The primary objective of this study is to test the hypothesis that chronic treatment with ranolazine can improve the symptomatic status of patients with ischemic heart disease by reducing the occurrence of palpitations.