Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients

NCT01040936 | Unknown Phase 4 DMC

• 2 other identifiers: RJH-091228RJH-2009
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome; intervention; outcome; patients diagnosed ad Non-ST elevation ACS; patients received PCI therapy

Outcome Measures

Primary Outcomes (1)

• The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization.

  one year

Secondary Outcomes (3)

• rate of peri-procedural myocardial infarction

  30days

• MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization

  30 days

• changes of left ventricular function at 30d after randomization

  30 days

Study Arms (2)

conventional group

ACTIVE COMPARATOR

patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.

Drug: Atorvastatin

intensive group

EXPERIMENTAL

patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.

Drug: Atorvastatin

Interventions

Atorvastatin DRUG

patients admitted for Non-ST elevation ACS will be treated by atorvastatin 20md/d for one year

conventional group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• finish informed consent
• age≥18y and under 75y
• diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
• willing to receive the coronary angiography and potential PCI therapy

You may not qualify if:

• patient was treated by statins before randomization
• stable angina or ST elevation myocardial infarction
• without informed consent
• abnormal liver function before randomization, (AST，ALT≥3ULN)
• active hepatitis or muscular disease
• impaired renal function with serum creatinine level \> 3mg/dl
• impaired left ventricular systolic function with LVEF\< 30%
• participating in other studies
• non-PCI treated patients after coronary angiography will be washed out

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin Hospital, Dept. of Cardiology

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Wei Feng Shen, MD, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Zhang, MD

CONTACT

+862164370045; zhangqnh@yahoo.com

Xin Chen, MD

CONTACT

+862164370045; rjchenxin@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: May 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 15, 2011

Record last verified: 2011-02

Locations

CN (1)