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. 2018 Nov 19;2018(11):CD012502. doi: 10.1002/14651858.CD012502.pub2

NCT01086020.

Methods Randomised open‐label parallel group study, 2 years follow‐up
Participants Inclusion Criteria:
  1. age 18 to 75 years;

  2. willing to receive the coronary angiography and potential PCI therapy


Exclusion Criteria:
  1. patients was treated by statins before randomisation;

  2. patient with ≤ 20% and ≥ 70% coronary narrowing and target lesion;

  3. ST elevation myocardial infarction less than 7 days;

  4. without informed consent;

  5. abnormal liver function before randomisation, (AST, ALT ≥ ULN);

  6. active hepatitis or muscular disease;

  7. impaired renal function with serum creatinine level > 3 mg/dL;

  8. impaired left ventricular function with LVEF > 30%;

  9. participate in other studies.

Interventions Atorvastatin 10 mg/day versus atorvastatin 5 mg/day plus ezetimibe 5 mg/day
Outcomes Primary endpoint: the change of coronary artery plaque volume measured by intravascular ultrasound (IVUS) at one year after randomisation.
Secondary endpoint: the composite of adverse cardiac events (MACE), including cardiac death, non‐fatal infarction and target vessel revascularisation at two years after randomisation.
Notes Study Start Date: January 2010
Recruitment Status: unknown
Last Update Posted: April 4, 2011
Location: China
Contact information: Ruiyan Zhang, MD; zhangruiyan@263.net
Contacted trialists to ask about status and anticipated completion date, but no response.