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Statin and Post-interventional Coronary Microcirculation Dysfunction

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A. Finished informed consent
  • B. Stable angina with clinical indication of coronary angiography
  • C. Age ≥ 21 year and ≤ 80 year

Exclusion Criteria:

  • A.Without informed consent
  • B.PCI target lesion is not adequate or not indicated for FFR/IMR study
  • C.Prior myocardial infarction or interventional procedure for PCI target vessel
  • D.Myocardial infarction within 30 days
  • E.Usage of statin, current or within 1 month
  • F.Prior bypass surgery
  • G.Impaired renal function (Creatinine > 2.0 mg/dL)
  • H.Impaired left ventricular function (ejection fraction < 40%)
  • I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN)
  • J.Contraindication for long-term antiplatelet agent or statin
  • K.Planning or potential of pregnancy
  • L.Neoplastic disease without evidence of treatment completion
  • M.Impaired general condition

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

atorvastatin

control

Arm Description

PCI with atorvastatin pre-treatment group

PCI without atorvastatin pre-treatment group

Outcomes

Primary Outcome Measures

Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel

Secondary Outcome Measures

Post-procedural troponin I
Post-procedural FFR
Post-procedural IMR comparison of target vessel with non-target vessel

Full Information

First Posted
December 13, 2012
Last Updated
December 13, 2012
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01751295
Brief Title
Statin and Post-interventional Coronary Microcirculation Dysfunction
Official Title
Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.
Detailed Description
Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet. In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
atorvastatin
Arm Type
Active Comparator
Arm Description
PCI with atorvastatin pre-treatment group
Arm Title
control
Arm Type
No Intervention
Arm Description
PCI without atorvastatin pre-treatment group
Intervention Type
Drug
Intervention Name(s)
Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI
Other Intervention Name(s)
lipinon
Primary Outcome Measure Information:
Title
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
Time Frame
within 1 year after PCI
Secondary Outcome Measure Information:
Title
Post-procedural troponin I
Time Frame
within 1 year after PCI
Title
Post-procedural FFR
Time Frame
within 1 year after PCI
Title
Post-procedural IMR comparison of target vessel with non-target vessel
Time Frame
within 1 year after PCI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A. Finished informed consent B. Stable angina with clinical indication of coronary angiography C. Age ≥ 21 year and ≤ 80 year Exclusion Criteria: A.Without informed consent B.PCI target lesion is not adequate or not indicated for FFR/IMR study C.Prior myocardial infarction or interventional procedure for PCI target vessel D.Myocardial infarction within 30 days E.Usage of statin, current or within 1 month F.Prior bypass surgery G.Impaired renal function (Creatinine > 2.0 mg/dL) H.Impaired left ventricular function (ejection fraction < 40%) I.Active hepatitis or abnormal hepatic transaminase level (> 3 ULN) J.Contraindication for long-term antiplatelet agent or statin K.Planning or potential of pregnancy L.Neoplastic disease without evidence of treatment completion M.Impaired general condition
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gang nam-Gu, Ilwon-Dong
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Statin and Post-interventional Coronary Microcirculation Dysfunction

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