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Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS (AVATAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01245803
Recruitment Status : Unknown
Verified July 2010 by Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
First Posted : November 23, 2010
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
Beijing Anzhen Hospital

Brief Summary:
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Angioplasty Drug: additional rosuvastatin loading Drug: placebo control Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome
Study Start Date : April 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rosuvastatin,one month,lipid lowering
additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI
Drug: additional rosuvastatin loading
additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI

Placebo Comparator: sugar pill, one month
sugar pill is given 18-24hr and 4-6hr before PCI as control
Drug: placebo control
sugar pill is given 18-24hr and 4-6hr before PCI as control




Primary Outcome Measures :
  1. peri-procedural myocardial damage [ Time Frame: 48 hours after PCI ]

Secondary Outcome Measures :
  1. MACE [ Time Frame: 30 days after PCI ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245803


Contacts
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Contact: Shujjuan Cheng, MD, PhD +861064456995 chengshujuan1@yahoo.com.cn
Contact: Shiying Li, MD +861064456541 yingying2000@gmail.com

Locations
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China, Beijing
the 28th division, Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Sponsors and Collaborators
Beijing Anzhen Hospital

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Responsible Party: HYan, BeijingAnzhen
ClinicalTrials.gov Identifier: NCT01245803    
Other Study ID Numbers: 6998
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: July 2010
Keywords provided by Beijing Anzhen Hospital:
rosuvastatin
angioplasty
acute coronary syndrome
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors