NCT01491256

Brief Summary

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.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

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

February 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

1.7 years

First QC Date

December 1, 2011

Last Update Submit

December 11, 2011

Conditions

Acute Coronary Syndrome

Keywords

Index of microcirculatory resistanceatorvastatindrug-eluting stentacute coronary syndrome

Outcome Measures

Primary Outcomes (1)

  • Index of microcirculatory resistance (IMR)

    After stent implantation and adjunctive balloon dilatation, final angiogram will be taken. If the final angiogram shows successful results, IMR will be measured and the procedure will be finished.

    Immediately after percutaneous coronary intervention

Secondary Outcomes (1)

  • Major Adverse Cardiovascular Events (death, myocardial infarction, target vessel failure

    1 year after index procedure

Study Arms (2)

High dose Atorvastatin

ACTIVE COMPARATOR

Arm of pre-procedural high dose atorvastatin loading

Drug: Pre-procedural High dose atorvastatin loading

Control

PLACEBO COMPARATOR

No pre-procedural high dose atorvastatin loading

Drug: No pre-procedural high-dose atorvastatin loading

Interventions

Pre-procedural High dose atorvastatin loadingDRUG

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

Also known as: Lipitor (Pfizer)
High dose Atorvastatin
No pre-procedural high-dose atorvastatin loadingDRUG

atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention

Also known as: Lipitor (Pfizer)
Control

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangwon National University Hospital

Chuncheon, 200-722, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Bong-Ki Lee, MD, PhD

    KangWon National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bong-Ki Lee, MD, PhD

CONTACT

+82-10-6373-9290nicedr@nate.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistance Professor of Medicine, Kangwon National University School of Medicine

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 13, 2011

Study Start

February 1, 2010

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

KR(1)