NCT01245803

Brief Summary

Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 23, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

November 22, 2010

Last Update Submit

November 22, 2010

Conditions

Acute Coronary SyndromeAngioplasty

Keywords

rosuvastatinangioplastyacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • peri-procedural myocardial damage

    48 hours after PCI

Secondary Outcomes (1)

  • MACE

    30 days after PCI

Study Arms (2)

rosuvastatin,one month,lipid lowering

EXPERIMENTAL

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

Drug: additional rosuvastatin loading

sugar pill, one month

PLACEBO COMPARATOR

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

Drug: placebo control

Interventions

additional rosuvastatin loadingDRUG

additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI

rosuvastatin,one month,lipid lowering
placebo controlDRUG

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

sugar pill, one month

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old
  • diagnosed as acute coronary syndrome
  • Plan to PCI

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the 28th division, Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Shujjuan Cheng, MD, PhD

CONTACT

+861064456995chengshujuan1@yahoo.com.cn

Shiying Li, MD

CONTACT

+861064456541yingying2000@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 23, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

November 23, 2010

Record last verified: 2010-07

Locations

CN(1)