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

NCT02423265.

Trial name or title NCT02423265
Methods Study design: parallel‐group trial
Duration of follow‐up: 9 weeks
Method of randomisation: not described
Method of concealment of allocation: not described
Blinding: Double‐blind (Subject, Investigator, Outcomes Assessor)
Power calculation: not mentioned
Phases of the study: 2 (treatment phase, follow‐up phase)
Participants Country of enrolment: not described
Setting/location: not specified
Diagnostic criteria (stable angina pectoris): not described
Comorbidities: percutaneous coronary intervention plus stent implantation
Inclusion criteria:
  • Angiographically proven coronary artery disease with chronic stable angina for at least 3 months.

  • Abnormal stress test (treadmill ECG, nuclear stress test, dobutamine stress echocardiogram or stress perfusion cardiac MRI)

  • ≥ 1 chronically occluded coronary artery of a dominant coronary vessel or the left anterior descending artery and/or ≥ 1 occluded vein graft to chronically occluded native coronary vessel

  • Subjects must be taking a minimum of 2 anti‐anginal agents


Exclusion criteria:
  • LVEF < 40

  • Terminal illness such as cancer

  • Occluded recessive coronary vessel

  • Hepatic insufficiency,

  • Liver cirrhosis,

  • Prolonged QT interval on ECG,

  • Severe renal failure (see below), Excluding patients with CrCl < 30

  • Drugs that are strong inhibitors of CYP3A such as, ketoconazole, macrolide antibiotics and HIV protease inhibitors.

  • Limit Ranolazine to 500 mg BID in patients on concurrent diltiazem/verapamil

  • Limit concurrent simvastatin to 20 mg/day

  • Limit concurrent metformin to 1700 mg/day

  • Inability to have an MRI scan/known claustrophobia

Interventions Number of intervention groups: 3
Concomitant medications: standard therapy (not described)
Excluded medications: not mentioned
Placebo group
Intervention:placebo with up‐titration after 1 week
Duration of intervention: 9 weeks
Ranolazine group
Intervention: ranolazine (type of formulation not specified) 1000 mg twice daily (up‐titrated after 1‐week 500 mg twice daily)
Duration of intervention: 9 weeks
Outcomes Total number of outcomes: 4 (cardiac MRI strain, dobutamine wall motion scoring index, quality of life, ETT parameters)
OUTCOMES
Quality of life
Outcome definition: measured with 3 scales (SAQ, DASI, SF‐12)
Method and unit of measurement: total score
Time points to report: 9 weeks
Starting date June 2015
Contact information Ashesh N Buch, MB.ChB, M.D. bucha@ecu.edu
Notes