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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Beijing Anzhen Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01245803
First Posted: November 23, 2010
Last Update Posted: November 23, 2010
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.
Information provided by:
Beijing Anzhen Hospital
  Purpose
Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Condition Intervention Phase
Acute Coronary Syndrome Angioplasty Drug: additional rosuvastatin loading Drug: placebo control Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beijing Anzhen Hospital:

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

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

Estimated Enrollment: 400
Study Start Date: April 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  Contacts and Locations
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
Contact: Shujjuan Cheng, MD, PhD +861064456995 chengshujuan1@yahoo.com.cn
Contact: Shiying Li, MD +861064456541 yingying2000@gmail.com

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

Responsible Party: HYan, BeijingAnzhen
ClinicalTrials.gov Identifier: NCT01245803     History of Changes
Other Study ID Numbers: 6998
First Submitted: November 22, 2010
First Posted: November 23, 2010
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:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents


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