Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS

NCT ID: NCT01245803

Last Updated: 2010-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-05-31

Brief Summary

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Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI

Detailed Description

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Conditions

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Acute Coronary Syndrome Angioplasty

Keywords

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rosuvastatin angioplasty acute coronary syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rosuvastatin,one month,lipid lowering

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

Group Type EXPERIMENTAL

additional rosuvastatin loading

Intervention Type DRUG

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

sugar pill, one month

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

Group Type PLACEBO_COMPARATOR

placebo control

Intervention Type DRUG

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

Interventions

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additional rosuvastatin loading

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

Intervention Type DRUG

placebo control

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role lead

Responsible Party

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BeijingAnzhen

Locations

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the 28th division, Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shujjuan Cheng, MD, PhD

Role: CONTACT

Phone: +861064456995

Email: [email protected]

Shiying Li, MD

Role: CONTACT

Phone: +861064456541

Email: [email protected]

Other Identifiers

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6998

Identifier Type: -

Identifier Source: org_study_id