Intensive Statin Treatment in Chinese Coronary Artery Disease Patients Undergoing PCI

Stable Angina Pectoris Clinical Trial

— ISCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293097
• Other study ID #: ISCAP
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2011
• Last updated: April 28, 2013
• Start date: June 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2013
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2884
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Infarction
• Myocardial Ischemia
• Non-ST Segment Elevation Myocardial Infarction
• Stable Angina Pectoris
• Unstable Angina Pectoris

Intervention

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

Locations

Country	Name	City	State
China	Division of Cardiology, Peking University First Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Post-procedural change of inflammatory biomarkers (hs-CRP)	Post-procedural change of inflammatory biomarkers (hs-CRP)	24 hours after PCI	No
Secondary	Morbidity of CIN	Morbidity of CIN	48 hours after PCI	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No

External Links

•   Related Info and e-CRF data.