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

NCT01646307 | Unknown Phase 4 DMC

• 1 other identifier: ARISE-001
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Focus of Study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• changes in myocardial biomarkers (troponin I, Creatine kinase-MB)

  24 hours after PCI

Study Arms (3)

standard care group

PLACEBO COMPARATOR

patients receive atorvastatin 20 mg/d

Drug: Atorvastatin

intensive rosuvastatin

ACTIVE COMPARATOR

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

Drug: Rosuvastatin

intensive atorvastatin

ACTIVE COMPARATOR

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

Interventions

Atorvastatin DRUG

intensive atorvastatin; standard care group

Rosuvastatin DRUG

intensive rosuvastatin

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, 100029, China

RECRUITING

MeSH Terms

Interventions

Atorvastatin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Officials

• Yu-Jie Zhou, MD, PhD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Gao, MD

CONTACT

86 18610323937; feigao.md@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Anzhen Hospital

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 20, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 20, 2012

Record last verified: 2012-07

Locations

CN (1)