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Clinical Trials/NCT01245894
NCT01245894
Completed
Phase 4

Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation

Odense University Hospital1 site in 1 country87 target enrollmentNovember 2007

Overview

Phase
Phase 4
Intervention
Low-dose Rosuvastatin
Conditions
Myocardial Infarction [C14.907.585.500]
Sponsor
Odense University Hospital
Enrollment
87
Locations
1
Primary Endpoint
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The aim of this study was to measure the effect of low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • ST-segment elevation myocardial infarction
  • no prior treatment with statins and
  • a non significant lesion in one of the two non-culprit coronary arteries

Exclusion Criteria

  • age below 18 or above 81 years,
  • unconscious patients,
  • serum creatinine \> 176μmol/L,
  • hypothyroidism ((TSH \> 1.5 x ULN (upper limit of normal)),
  • current liver disease (ALAT \> 2 x ULN),
  • unexplained creatine kinase \> 3 x ULN,
  • alcohol or drug abuse within the last five years,
  • prior myopathy or serious hypersensitivity reaction caused by statins,
  • women with childbearing potential who were not using chemical or mechanical contraception,
  • pregnant or breastfeeding women,

Arms & Interventions

Low-dose Rosuvastatin

5mg Rosuvastatin/day

Intervention: Low-dose Rosuvastatin

High-dose Rosuvastatin

Rosuvastatin 40mg/day

Intervention: High-dose Rosuvastatin

Outcomes

Primary Outcomes

The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).

Time Frame: One year

Secondary Outcomes

  • The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.(One year)

Study Sites (1)

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