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

November 22, 2010 updated by: Beijing Anzhen Hospital

Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome

Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • the 28th division, Beijing Anzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peri-procedural myocardial damage
Time Frame: 48 hours after PCI
48 hours after PCI

Secondary Outcome Measures

Outcome Measure
Time Frame
MACE
Time Frame: 30 days after PCI
30 days after PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

May 1, 2011

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 22, 2010

First Posted (Estimate)

November 23, 2010

Study Record Updates

Last Update Posted (Estimate)

November 23, 2010

Last Update Submitted That Met QC Criteria

November 22, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6998

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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