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Index of Microcirculatory Resistance After Drug-Eluting Stent Implantation With High Dose Atorvastatin Loading

NCT ID: NCT01491256

Last Updated: 2011-12-13

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-02-29

Brief Summary

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Pre-treatment with statins decreased the incidence of cardiac enzyme increase after percutaneous coronary intervention (PCI) and distal embolization suspected to cause post-PCI myocardial damage. This study evaluates the effect of high dose atorvastatin pre-treatment on post-procedural index of microcirculatory resistance (IMR) values that are introduced for assessing the status of the microcirculation.

Detailed Description

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One hundred patients with non-ST elevation acute coronary syndrome will be randomly assigned to either high dose atorvastatin pre-treatment group(80 mg loading within 24 hours plus 40mg busting within 2 hours before PCI) or control group(atorvastatin 10mg administration within 24 hours before PCI). An intracoronary pressure/temperature sensor-tipped guidewire is used. Thermodilution curves are obtained during maximal hyperemia. The IMR was calculated from the ratio of the mean distal coronary pressure at maximal hyperemia to the inverse of mean hyperemic transit time. Creatine kinase-myocardial band(CK-MB) and CRP level will be measured at baseline and at 12\~24 hours after PCI.

Conditions

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Acute Coronary Syndrome

Keywords

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Index of microcirculatory resistance atorvastatin drug-eluting stent acute coronary syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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High dose Atorvastatin

Arm of pre-procedural high dose atorvastatin loading

Group Type ACTIVE_COMPARATOR

Pre-procedural High dose atorvastatin loading

Intervention Type DRUG

Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention

Control

No pre-procedural high dose atorvastatin loading

Group Type PLACEBO_COMPARATOR

No pre-procedural high-dose atorvastatin loading

Intervention Type DRUG

atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

Interventions

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Pre-procedural High dose atorvastatin loading

Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention

Intervention Type DRUG

No pre-procedural high-dose atorvastatin loading

atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

Intervention Type DRUG

Other Intervention Names

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Lipitor (Pfizer) Lipitor (Pfizer)

Eligibility Criteria

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Inclusion Criteria

* Patients of Non-ST elevation acute coronary syndrome planed to elective percutaneous coronary intervention

Exclusion Criteria

* ST elevation myocardial infarction
* Cardiogenic shock
* Congestive heart failure with pulmonary edema
* Severe left ventricular dysfunction (LVEF \< 30%)
* History of previous coronary revascularization therapy
* chronic total coronary occlusion
* 3 vessel disease
* Target lesion at distal segments or branches
* Ostial lesion
* Excessive coronary calcification or thrombi
* Elevated transaminase
* Renal dysfunction (serum creatinine \> 2.0mg/dL
* History of myopathy
* Contra-indication to anti-platelet therapy
* Not indicated for percutaneous coronary intervention
* Other co-morbidity with life expectancy less than 1 year
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Korean Society of Circulation

OTHER

Sponsor Role lead

Responsible Party

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Bong-Ki Lee

Assistance Professor of Medicine, Kangwon National University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bong-Ki Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KangWon National University Hospital

Locations

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Kangwon National University Hospital

Chuncheon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Bong-Ki Lee, MD, PhD

Role: CONTACT

Phone: +82-10-6373-9290

Email: [email protected]

Facility Contacts

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Bong-Ki Lee, MD, PhD

Role: primary

Other Identifiers

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RESIST-ACS

Identifier Type: -

Identifier Source: org_study_id