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. 2017 Feb 8;2017(2):CD011747. doi: 10.1002/14651858.CD011747.pub2

NCT01495520.

Trial name or title NCT01495520
Methods Study design: cross‐over trial
Duration of follow‐up: 30 days
Method of randomisation: not described
Method of concealment of allocation: not described
Blinding: double‐blind (Subject, Caregiver, Investigator)
Power calculation: not mentioned
Phases of the study: 1 (treatment phase)
Participants Total number: 100 (estimated)
Country of enrolment: Italy
Setting/location: not specified
Diagnostic criteria (stable angina pectoris): coronary artery disease (macrovascular angina)
Comorbidities: none
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

Interventions Number of intervention groups: 2
Concomitant medications: not described
Excluded medications: not described
Placebo group
Intervention: placebo
Duration of intervention: 30 days
Ranolazine group
Intervention: ranolazine (type of formulation not specified) 750 mg twice daily
Duration of intervention: 30 days
Outcomes Total number of outcomes: 2 (occurrence of symptoms of palpitations, occurrence of arrhythmia in case of symptoms of palpitations)
OUTCOMES
No outcome meets the inclusion criteria
Starting date January 2014
Contact information Francesco Pelliccia, MD
+39064997
f.pelliccia@mclink.it
Notes Source of funding: University of Roma La Sapienza