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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Beijing Anzhen Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01245803
First received: November 22, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • peri-procedural myocardial damage [ Time Frame: 48 hours after PCI ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACE [ Time Frame: 30 days after PCI ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: HYan, BeijingAnzhen
ClinicalTrials.gov Identifier: NCT01245803     History of Changes
Other Study ID Numbers: 6998
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: China: Ministry of Health

Keywords provided by Beijing Anzhen Hospital:
rosuvastatin
angioplasty
acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Rosuvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013