Ranolazine for Improving Symptoms of Palpitations (RYPPLE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01495520
First received: December 15, 2011
Last updated: March 6, 2013
Last verified: March 2013

December 15, 2011
March 6, 2013
January 2014
December 2014   (final data collection date for primary outcome measure)
Occurrence of symptoms of palpitations [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
Occurrence of symptoms of palpitations
Same as current
Complete list of historical versions of study NCT01495520 on ClinicalTrials.gov Archive Site
Occurrence of arrhythmia in case of symptoms of palpitations [ Time Frame: Up to 30 days ] [ Designated as safety issue: No ]
Definition of presence, number, type and duration of the arrhythmia in case of the patient-reported symptoms of palpitations
Same as current
Not Provided
Not Provided
 
Ranolazine for Improving Symptoms of Palpitations
Ranolazine for the Treatment of sYmPtoms of PaLpitations in patiEnts With Ischemic Heart Disease - The RYPPLE Trial

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Ischemic Heart Disease
  • Drug: Ranolazine
    os, pill, 750 mg, b.i.d., 30 days
    Other Name: Ranexa TM, Gilead, US
  • Drug: Placebo
    os, pill, b.i.d., 30 days
    Other Name: Placebo
  • Active Comparator: Ranolazine
    Patients will receive ranolazine 750 mg bid for 30 days
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Patients will receive placebo for 30 days
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
December 2016
December 2014   (final data collection date for primary outcome measure)

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 with beta-blockers and/or calcium antagonists.

Exclusion Criteria:

  • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours
  • Severe renal failure
  • Severe hepatic failure
Both
Not Provided
No
Contact: Francesco Pelliccia, MD +39064997 f.pelliccia@mclink.it
Not Provided
 
NCT01495520
671/2011/D
No
Francesco Pelliccia, University of Roma La Sapienza
University of Roma La Sapienza
Not Provided
Principal Investigator: Francesco Pelliccia, MD University Sapienza
University of Roma La Sapienza
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP