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

NCT01304095.

Methods Study design: parallel‐group trial
Duration of follow‐up: 6 months
Method of randomisation: not described
Method of concealment of allocation: not described
Blinding: open‐label
Power calculation: not mentioned
Phases of the study: 1 (treatment phase)
Participants Total number: 160 (estimated)
Country of enrolment: USA
Setting/location: not specified
Diagnostic criteria (stable angina pectoris): symptoms of angina with evidence of stable CAD (macrovascular angina)
Comorbidities: metabolic syndrome
Inclusion criteria:
  • Evidence of stable Coronary Artery Disease

    • MI > 30 days prior to enrolment

    • PCI > 30 days prior to enrolment

    • CABG > 30 days prior to enrolment

    • Angiography showing > 50% stenosis in a major vessel, branch or bypass graft > 30 days prior to enrolment

  • Metabolic Syndrome as evidenced by at least one of the following risk factors:

    • Abdominal Obesity (elevated waist circumference)

      • Men ‐ waist circumference ≥ 40 inches (102 cm) Asians/Asian Americans ≥ 35.5 inches (90 cm)

      • Women ‐ waist circumference ≥ 35 inches (88 cm) Asians/Asian Americans ≥ 31.5 inches (80 cm)

    • Atherogenic dyslipidaemia (either one or both)

      • Triglycerides ≥ 150 mg/dL

      • Reduced HDL Men ‐ HDL ≤ 40 mg/dL Women ‐ HDL ≤ 50 mg/dL

    • Elevated Blood Pressure (equal to or greater than 130/85)

    • Elevated fasting glucose (equal to or greater than 100 mg/dL)

Interventions Number of intervention groups: 2
Concomitant medications: standard medical therapy
Excluded medications: those mentioned in exclusion criteria
Control group
Intervention: no treatment
Duration of intervention: 6 months
Ranolazine group
Intervention: ranolazine (type of formulation not specified) 500/1000 mg twice daily
Duration of intervention: 6 months
Outcomes Total number of outcomes: 6 (ETT parameters, fasting glucose, angina (SAQ scale), concomitant medications, lipid profile, HbA1c)
OUTCOMES
No outcome meets inclusion criteria
Notes