Intensive Statin Therapy in PCI Patient With Acute Coronary Syndrome

Myocardial Infarction Clinical Trial

— PCI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01372839
• Other study ID #: xj050511
• Status: Recruiting
• Phase: Phase 4
• First received: June 10, 2011
• Last updated: June 11, 2011
• Start date: July 2010

Study information

• Verified date: July 2010
• Source: Xijing Hospital
• Contact: Ling Tao, M.D Ph.D
• Phone: +86-15002955798
• Email: lingtao2006[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Unstable Angina

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day major adverse cardiovascular events (combined endpoints of cardiac death, myocardial infarction, and target vessel revascularization ) after PCI		30-day	Yes
Secondary	Post-procedural change of inflammatory biomarkers (hs-CRP)		24h	No
Secondary	Morbidity of CIN		48h	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	serum adiponectin concentration		6 months	No