MedDataX Logo

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

NCT ID: NCT01646307

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Focus of Study

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard care group

patients receive atorvastatin 20 mg/d

Group Type PLACEBO_COMPARATOR

Atorvastatin

Intervention Type DRUG

intensive rosuvastatin

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

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

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;

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Atorvastatin

Intervention Type DRUG

Rosuvastatin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yujie Zhou

Vice President of Anzhen Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yu-Jie Zhou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beijing Anzhen Hospital

Beijing, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fei Gao, MD

Role: CONTACT

Phone: 86 18610323937

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ARISE-001

Identifier Type: -

Identifier Source: org_study_id