Statin and Post-interventional Coronary Microcirculation Dysfunction
Effect of Statin on the Post-interventional Coronary Microcirculation Dysfunction
1 other identifier
interventional
84
1 country
1
Brief Summary
The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable coronary-artery-disease
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedDecember 17, 2012
December 1, 2012
1.7 years
December 13, 2012
December 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Post-procedural IMR of PCI target vessel Post-procedural IMR of PCI target vessel
within 1 year after PCI
Secondary Outcomes (3)
Post-procedural troponin I
within 1 year after PCI
Post-procedural FFR
within 1 year after PCI
Post-procedural IMR comparison of target vessel with non-target vessel
within 1 year after PCI
Study Arms (2)
atorvastatin
ACTIVE COMPARATORPCI with atorvastatin pre-treatment group
control
NO INTERVENTIONPCI without atorvastatin pre-treatment group
Interventions
Eligibility Criteria
You may qualify if:
- A. Finished informed consent
- B. Stable angina with clinical indication of coronary angiography
- C. Age ≥ 21 year and ≤ 80 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, Gang nam-Gu, Ilwon-Dong, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
December 13, 2012
First Posted
December 17, 2012
Study Start
December 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
December 17, 2012
Record last verified: 2012-12