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NCT01245803 Clinical Trial

Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS

Acute Coronary Syndrome Clinical Trial

— AVATAR  

Official title:
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01245803
Other study ID # 6998
Secondary ID
Status Recruiting
Phase Phase 4
First received November 22, 2010
Last updated November 22, 2010
Start date April 2010
Est. completion date May 2011

Study information
Verified date July 2010
Source Beijing Anzhen Hospital
Contact Shujjuan Cheng, MD, PhD
Phone +861064456995
Email chengshujuan1@yahoo.com.cn
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date May 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• additional rosuvastatin loading
additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI
• placebo control
sugar pill is given 18-24hr and 4-6hr before PCI as control

Locations
Country Name City State
China the 28th division, Beijing Anzhen Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary peri-procedural myocardial damage 48 hours after PCI Yes
Secondary MACE 30 days after PCI Yes
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