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

Primary Purpose

Acute Coronary Syndrome, Angioplasty

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
additional rosuvastatin loading
placebo control
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring rosuvastatin, angioplasty, acute coronary syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • the 28th division, Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rosuvastatin,one month,lipid lowering

sugar pill, one month

Arm Description

additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI

sugar pill is given 18-24hr and 4-6hr before PCI as control

Outcomes

Primary Outcome Measures

peri-procedural myocardial damage

Secondary Outcome Measures

MACE

Full Information

First Posted
November 22, 2010
Last Updated
November 22, 2010
Sponsor
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01245803
Brief Title
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS
Acronym
AVATAR
Official Title
Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
May 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Angioplasty
Keywords
rosuvastatin, angioplasty, acute coronary syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rosuvastatin,one month,lipid lowering
Arm Type
Experimental
Arm Description
additional rosuvastatin(10mg) is given at 18hr and 4-6hr before PCI
Arm Title
sugar pill, one month
Arm Type
Placebo Comparator
Arm Description
sugar pill is given 18-24hr and 4-6hr before PCI as control
Intervention Type
Drug
Intervention Name(s)
additional rosuvastatin loading
Intervention Description
additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI
Intervention Type
Drug
Intervention Name(s)
placebo control
Intervention Description
sugar pill is given 18-24hr and 4-6hr before PCI as control
Primary Outcome Measure Information:
Title
peri-procedural myocardial damage
Time Frame
48 hours after PCI
Secondary Outcome Measure Information:
Title
MACE
Time Frame
30 days after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shujjuan Cheng, MD, PhD
Phone
+861064456995
Email
chengshujuan1@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shiying Li, MD
Phone
+861064456541
Email
yingying2000@gmail.com
Facility Information:
Facility Name
the 28th division, Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS

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