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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01646307

Collaborator

(none)

1,000

Enrollment

Location

Arms

Duration (Months)

58.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Focus of Study	Drug: Atorvastatin Drug: Rosuvastatin	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2012

Anticipated Primary Completion Date :

Jan 1, 2013

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: standard care group patients receive atorvastatin 20 mg/d	Drug: Atorvastatin
Active Comparator: intensive rosuvastatin administrated with rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI	Drug: Rosuvastatin
Active Comparator: intensive atorvastatin patients will be administrated with atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI;	Drug: Atorvastatin

Arm

Intervention/Treatment

Placebo Comparator: standard care group

patients receive atorvastatin 20 mg/d

Drug: Atorvastatin

Active Comparator: intensive rosuvastatin

administrated with rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI

Drug: Rosuvastatin

Active Comparator: intensive atorvastatin

patients will be administrated with atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI;

Drug: Atorvastatin

Outcome Measures

Primary Outcome Measures

30-day MACCEs after PCI [30-day 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

Secondary Outcome Measures

changes in myocardial biomarkers (troponin I, Creatine kinase-MB) [24 hours after PCI]
changes in myocardial biomarkers (troponin I, Creatine kinase-MB)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing		China	100029

Sponsors and Collaborators

Beijing Anzhen Hospital

Investigators

Principal Investigator: Yu-Jie Zhou, MD, PhD, Beijing Anzhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yujie Zhou, Vice President of Anzhen Hospital, Beijing Anzhen Hospital

ClinicalTrials.gov Identifier:

NCT01646307

Other Study ID Numbers:

ARISE-001

First Posted:

Jul 20, 2012

Last Update Posted:

Jul 20, 2012

Last Verified:

Jul 1, 2012

Additional relevant MeSH terms:

Atorvastatin

Rosuvastatin Calcium

Study Results

No Results Posted as of Jul 20, 2012