Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS

Phase 4

• Conditions: Acute Coronary Syndrome; Angioplasty
• Interventions: Drug: additional rosuvastatin loading; Drug: placebo control

• Registration Number: NCT01245803
• Lead Sponsor: Beijing Anzhen Hospital

Brief Summary

Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-07
• Study First Submitted: 2010-11-22
• Study First Submitted QC: 2010-11-22
• Last Update Submitted: 2010-11-22
• Study First Posted: 2010-11-23
• Last Update Posted: 2010-11-23
• Primary Completion: 2011-04
• Study Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 18-75 year old
• diagnosed as acute coronary syndrome
• Plan to PCI

Exclusion Criteria

• STEMI patient
• emergency PCI(<2h) for NSTE-ACS
• History of liver disease and myopathy (ALT/AST>3 x upper limit of normal,CK>5 x upper limit of normal)
• TG>500mg/dl,CCr<30ml/min
• inflammatory disease
• allergic to rosuvastatin
• nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rosuvastatin,one month,lipid lowering	additional rosuvastatin loading	additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI
sugar pill, one month	placebo control	sugar pill is given 18-24hr and 4-6hr before PCI as control

Primary Outcome Measures

Name	Time	Method
peri-procedural myocardial damage	48 hours after PCI

Secondary Outcome Measures

Name	Time	Method
MACE	30 days after PCI

Trial Locations

Locations (1)

the 28th division, Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China