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

Sponsor

Peking University First Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01293097

Collaborator

(none)

2,884

Enrollment

Location

Arms

Duration (Months)

180.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non-ST Segment Elevation Myocardial Infarction Unstable Angina Pectoris Stable Angina Pectoris	Drug: Atorvastatin Drug: Statin	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2884 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Atorvastatin Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care Other Names: Liptor
Other: Usual care Usual care, but statin dose should not be higher than that described in exclusion criteria.	Drug: Statin Usual care, but statin dose should not be higher than that described in exclusion criteria Other Names: Liptor Zocor Pravachol Lescol

Arm

Intervention/Treatment

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

Drug: Atorvastatin

Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care

Other Names:

Liptor

Other: Usual care

Usual care, but statin dose should not be higher than that described in exclusion criteria.

Drug: Statin

Usual care, but statin dose should not be higher than that described in exclusion criteria

Other Names:

Liptor

Zocor

Pravachol

Lescol

Outcome Measures

Primary Outcome Measures

30-day MACEs after PCI [30 days after PCI]
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI

Secondary Outcome Measures

Post-procedural change of inflammatory biomarkers (hs-CRP) [24 hours after PCI]
Post-procedural change of inflammatory biomarkers (hs-CRP)
Morbidity of CIN [48 hours after PCI]
Morbidity of CIN
Elevation of ALT, AST and CK [6 months after PCI]
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 [6 months after PCI]
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 [6 months after PCI]
Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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