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

• ClinicalTrials.gov Identifier: NCT01293097
• Recruitment Status: Completed
• First Posted: February 10, 2011
• Last Update Posted: April 30, 2013
• Sponsor: Peking University First Hospital
• Information provided by (Responsible Party): Yong Huo, Peking University First Hospital

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 (Clinical Trial)
• 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: June 2010
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: October 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 Name: Liptor
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 :

1. 30-day MACEs after PCI [ Time Frame: 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 :

1. Post-procedural change of inflammatory biomarkers (hs-CRP) [ Time Frame: 24 hours after PCI ]
   Post-procedural change of inflammatory biomarkers (hs-CRP)
2. Morbidity of CIN [ Time Frame: 48 hours after PCI ]
   Morbidity of CIN
3. Elevation of ALT, AST and CK [ Time Frame: 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.
4. Adverse events [ Time Frame: 6 months after PCI ]
   Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events
5. Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events [ Time Frame: 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

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China

Division of Cardiology, Peking University First Hospital

Beijing, China, 10034

Sponsors and Collaborators

Peking University First Hospital

Investigators

• Principal Investigator: Yong Huo, MD; Peking University First Hospital

More Information

• Responsible Party: Yong Huo, Director, Department of cardiology, Peking University First Hospital
• ClinicalTrials.gov Identifier: NCT01293097
• Other Study ID Numbers: ISCAP
• First Posted: February 10, 2011
• Last Update Posted: April 30, 2013
• Last Verified: April 2013

Additional relevant MeSH terms:

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