Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing PCI (ARISE)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Focus of Study |
Drug: Atorvastatin Drug: Rosuvastatin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing Percutaneous Coronary Intervention |
- 30-day MACCEs after PCI [ Time Frame: 30-day after PCI ] [ Designated as safety issue: No ]30-day major adverse cardio- and cerebralvascular events (combined endpoints of cardiac death, myocardial infarction, stroke, stent thrombosis and target vessel revascularization ) after PCI
- changes in myocardial biomarkers (troponin I, Creatine kinase-MB) [ Time Frame: 24 hours after PCI ] [ Designated as safety issue: No ]changes in myocardial biomarkers (troponin I, Creatine kinase-MB)
| Estimated Enrollment: | 1000 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 65 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Fei Gao, MD | 86 18610323937 | feigao.md@gmail.com |
| China | |
| Beijing Anzhen Hospital | Recruiting |
| Beijing, China, 100029 | |
| Sub-Investigator: Ying-Xin Zhao, MD | |
| Principal Investigator: Yu-Jie Zhou, MD, PhD | |
| Principal Investigator: | Yu-Jie Zhou, MD, PhD | Beijing Anzhen Hospital |
More Information
No publications provided
| Responsible Party: | Yujie Zhou, Vice President of Anzhen Hospital, Beijing Anzhen Hospital |
| ClinicalTrials.gov Identifier: | NCT01646307 History of Changes |
| Other Study ID Numbers: | ARISE-001 |
| Study First Received: | July 18, 2012 |
| Last Updated: | July 18, 2012 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Atorvastatin Rosuvastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013