Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing PCI

Focus of Study Clinical Trial

— ARISE  

Official title:

Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01646307
• Other study ID #: ARISE-001
• Status: Recruiting
• Phase: Phase 4
• First received: July 18, 2012
• Last updated: July 18, 2012
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2012
• Source: Beijing Anzhen Hospital
• Contact: Fei Gao, MD
• Phone: 86 18610323937
• Email: feigao.md[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, open label, parallel-group study is designed to investigate whether periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of cardiovascular events for Chinese elderly patients.

Description:

1800 elderly patients (>65 yr) with coronary artery disease undergoing elective PCI were randomized in 2:1 fashion into either intensive statin group or standard care group. Patients in intensive statin group is further randomized into two subgroups: administrated with either atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI; or rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI, while the standard care group receives atorvastatin 20 mg/d. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. The last visit will be at 6 months after PCI. Clinical data such as troponin, CK-MB, Scr, CCR, ALT, AST before and 24h to 48h after procedure will be recorded. 1000 eligible patients will be finally enrolled.The study will be conducted at 12 centers in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 80 Years

Eligibility

Inclusion Criteria:

65-80 years old Patients undergoing for elective percutaneous coronary intervention Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

• Patients undergoing emergency percutaneous coronary intervention

• Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin (such as simvastatin 20mg/d, pruvastatin 40mg/d, fluvastatin 80mg/d or rovastatin 5mg/d ) in the next 6 months, or needing to take fibrates or niacins simultaneously according to investigators' judgment.

• LDL-C < 1.8mmol/L in patients without statin therapy

• 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)

• WBC < 4×109/L or PLT < 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

• Accompanied with malignant disease or other disease, which cause life expectancy < 6 months

• Participating in other interventional clinical trials 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

• Focus of Study

Intervention

Drug:
• Atorvastatin

• Rosuvastatin

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day MACCEs after PCI	30-day major adverse cardio- and cerebralvascular events (combined endpoints of cardiac death, myocardial infarction, stroke, stent thrombosis and target vessel revascularization ) after PCI	30-day after PCI	No
Secondary	changes in myocardial biomarkers (troponin I, Creatine kinase-MB)	changes in myocardial biomarkers (troponin I, Creatine kinase-MB)	24 hours after PCI	No