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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Beijing Anzhen Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Yujie Zhou, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01646307
First received: July 18, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646307

Contacts
Contact: Fei Gao, MD 86 18610323937 feigao.md@gmail.com

Locations
China
Beijing Anzhen Hospital Recruiting
Beijing, China, 100029
Sub-Investigator: Ying-Xin Zhao, MD         
Principal Investigator: Yu-Jie Zhou, MD, PhD         
Sponsors and Collaborators
Beijing Anzhen Hospital
Investigators
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 July 22, 2014