Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI
Condition: Non-ST Segment Elevation Myocardial Infarction; Unstable Angina Pectoris; Stable Angina Pectoris
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Angina Pectoris; Angina, Stable; Angina, Unstable; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, open label, controlled, parallel group study is designed to test whether
      2-day high dose atorvastatin administration before PCI and 30-day continuous intensive
      atorvastatin treatment is superior to usual care, in terms of peri-PCI cardiovascular events,
      as well as 6-month prognosis. The goal is to set up an optimized protocol for peri-PCI statin
      treatment in Chinese CHD patients. Safety will also be observed.
    

Detailed description: 
      The study objective is to test whether 2-day high dose atorvastatin administration before PCI
      and 30-day continuous intensive atorvastatin treatment is superior to usual care, in terms of
      peri-PCI cardiovascular events, as well as 6-month prognosis.

      2160 patients with non-ST segment elevated acute coronary syndrome (ACS)or stable angina
      pectoris (SAP) scheduled for selective PCI are randomized into two groups. The study group is
      given atorvastatin 80 mg/d×2d before PCI while the control group receives usual care. After
      angiography, patients who are not undergoing PCI procedure will be excluded from the study as
      selection failure. After PCI procedure, the study group is given atorvastatin 40mg/d until 30
      days after PCI while the control group receive usual care. The last visit will be at 6 months
      after PCI. Patients data such as troponin, CK-MB, Scr, CCR, ALT, AST before and after
      procedure will be recorded. 1100 effective patients will be finally enrolled.

      The study will be conducted at about 54 centers in China. Data will be collected on 2,100
      NSTE or SAP patients undergoing PCI.

      Primary outcome: MACE within 30 days after PCI. Secondary outcome: Post-procedural change of
      inflammatory biomarkers (hs-CRP); Morbidity of CIN; Proportion of patients who experience at
      least once AST > 3ULN，ALT > 3ULN or CK > 5ULN after initiation of study treatment. Proportion
      of patients who experience at least once AST, ALT, or CK>ULN after initiation of study
      treatment; Proportion of patients who take reduced dose of atorvastatin, withdraw study
      treatment, or withdraw study due to adverse events; Combined endpoint of death, cardiac
      death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and
      cerebrovascular events within 6 months after PCI.
    

Intervention name(s): Atorvastatin; Statin
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care; Usual care, but statin dose should not be higher than that described in exclusion criteria
Other intervention name(s): Liptor; Liptor; Zocor; Pravachol; Lescol
Intervention MeSH terms: Atorvastatin; Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment