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

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.

Study Overview

• Status: Completed
• Conditions: Stable Angina Pectoris; Unstable Angina Pectoris; Non-ST Segment Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Atorvastatin; Drug: Statin

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 Type: Interventional
• Enrollment (Actual): 2884
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 10034
    • Division of Cardiology, Peking University First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Zocor; Pravachol; Lescol; Liptor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day MACEs after PCI	30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI	30 days after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-procedural change of inflammatory biomarkers (hs-CRP)	Post-procedural change of inflammatory biomarkers (hs-CRP)	24 hours after PCI
Morbidity of CIN	Morbidity of CIN	48 hours after PCI
Elevation of ALT, AST and CK	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.	6 months after PCI
Adverse events	Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events	6 months after PCI
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events	Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.	6 months after PCI

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 28, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Pravastatin
• Other Study ID Numbers: ISCAP