Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome (PCI)

The Safety and Efficacy of Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Compare with regular regimen, the aim of this study is to testify whether having more statin during PCI will benefit in Chinese population, and to find out optimal dose of the drug for patient after PCI.

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Unstable Angina
• Intervention / Treatment: Drug: Atorvastatin; Drug: Statin

Detailed Description

This study is designed to find out whether patients undergoing PCI can benefit from intensive atorvastatin treatment compared with routine treatment on chinese population.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Ling Tao, M.D Ph.D; Phone Number: +86-15002955798; Email: lingtao2006@gmail.com
      • Principal Investigator: Ling Tao, M.D Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18-85 years old
• Patients with clinical diagnosis of ACS
• Evidence of a personally signed and dated informed consent document

Exclusion Criteria:

• Taking or, needing to take atorvastatin over than 20mg/d or any other equivalent statin in the next 6 months, or needing to take fibrates simultaneously according to investigators' judgment.
• LDL-C < 1.8mmol/L in patients without statin therapy in 1 months
• 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)
• 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
• Pregnancy, lactation, or child bearing potential women without any effective contraception
• Accompanied with malignant disease or other disease, which cause life expectancy < 6 months
• Participating in other interventional clinical trails 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Atorvastatin; 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care	Drug: Atorvastatin; Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
Other: Usual care; statin dose should not be higher than that described in exclusion criteria.	Drug: Statin; Usual care, but statin dose should not be higher than that described in exclusion criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI	30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-procedural change of inflammatory biomarkers (hs-CRP)		24h
Morbidity of CIN		48h
Elevation of ALT, AST and CK	Proportion of patients who experience at least once AST>3UNL，ALT>3UNL or CK>5UNL after initiation of study treatment. Proportion of patients who experience at least once AST, ALT, or CK>UNL after initiation of study treatment.	6 months
Number of Participants with Adverse Events	Proportion of patients who take reduced dose of atorvastatin, withdraw study treatment, or withdraw study due to adverse events	6 months
Combined endpoint of MACEs, cardiac hospitalization and cerebrovascular events	Combined endpoint of death, cardiac death, myocardial infarction, heart failure, cardiac hospitalization, revascularization, and cerebrovascular events within 6 months after PCI.	6 months
serum adiponectin concentration		6 months

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Director: Yong Huo, MD, Division of Cardiology, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2012
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 11, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): June 14, 2011
• Last Update Submitted That Met QC Criteria: June 11, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Unstable Angina; Myocardial Infarction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Myocardial Infarction; Infarction; Acute Coronary Syndrome; Angina, Unstable; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: xj050511

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No