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Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI (ISCAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01293097
First received: February 9, 2011
Last updated: April 28, 2013
Last verified: April 2013

February 9, 2011
April 28, 2013
June 2010
October 2011   (final data collection date for primary outcome measure)
30-day MACEs after PCI [ Time Frame: 30 days after PCI ] [ Designated as safety issue: No ]
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI
Same as current
Complete list of historical versions of study NCT01293097 on ClinicalTrials.gov Archive Site
  • Post-procedural change of inflammatory biomarkers (hs-CRP) [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]
    Post-procedural change of inflammatory biomarkers (hs-CRP)
  • Morbidity of CIN [ Time Frame: 48 hours after PCI ] [ Designated as safety issue: No ]
    Morbidity of CIN
  • Elevation of ALT, AST and CK [ Time Frame: 6 months after PCI ] [ Designated as safety issue: Yes ]
    Proportion of patients who experience at least once AST>3UNL,ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment.
  • Adverse events [ Time Frame: 6 months after PCI ] [ Designated as safety issue: Yes ]
    Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events
  • Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events [ Time Frame: 6 months after PCI ] [ Designated as safety issue: No ]
    Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.
Same as current
Not Provided
Not Provided
 
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI
Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing Percutaneous Coronary Intervention(PCI)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Non-ST Segment Elevation Myocardial Infarction
  • Unstable Angina Pectoris
  • Stable Angina Pectoris
  • Drug: Atorvastatin
    Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
    Other Name: Liptor
  • Drug: Statin
    Usual care, but statin dose should not be higher than that described in exclusion criteria
    Other Names:
    • Liptor
    • Zocor
    • Pravachol
    • Lescol
  • Active Comparator: Intensive statin therapy
    Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
    Intervention: Drug: Atorvastatin
  • Usual care
    Usual care, but statin dose should not be higher than that described in exclusion criteria.
    Intervention: Drug: Statin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2884
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20-75 years old
  • Patients with clinical diagnosis of NSTE-ACS (unstable angina or NSTE acute myocardial infarction) or stable angina pectoris (SAP) scheduled for selective coronary angiography
  • Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

  • Patients presenting with ST-segment elevation acute myocardial infarction (STEMI) or high risk NSTE-ACS, warranting emergency coronary angiography:
  • Experienced STEMI within previous 30 days
  • Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pravastatin 40mg/d, fluvastatin 80mg/d or rosuvastatin 5mg/d ) in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
  • Anticipated repeated PCI within 6 months
  • LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
  • Endstage congestive heart failure, or LVEF < 30%
  • Active hepatic disease or hepatic dysfunction, or AST/ALT > 1.5UNL
  • Myopathy or increased creatine kinase (CK>2 UNL)
  • White blood cell < 4×109/L or platelet < 100×109/L
  • Severe renal dysfunction(Scr > 3 mg/dl or 264μmol/L)
  • Allergic or experienced serious adverse reaction to HMG-CoA reductase, or ineligible to take statin as investigator's judgment
  • Severe aortic valve stenosis or severe mitral stenosis, Obstructive hypertrophic cardiomyopathy, pericardial diseases
  • Pregnancy, lactation, or child bearing potential women without any effective contraception
  • Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
  • Participating in other interventional clinical trails using drugs or devices
  • Patients with any condition which, in the investigator's judgment, might increase the risk to the subject for any adverse event or abnormal laboratory finding
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01293097
ISCAP
Yes
Yong Huo, Peking University First Hospital
Peking University First Hospital
Not Provided
Principal Investigator: Yong Huo, MD Peking University First Hospital
Peking University First Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP