Myocardial Infarction [C14.907.585.500] Clinical Trial
Official title:
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on the Coronary Microcirculation
| Verified date | November 2007 |
| Source | Odense University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Denmark: Danish Medicines Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 87 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 81 Years |
| Eligibility |
Inclusion Criteria: 1. ST-segment elevation myocardial infarction 2. no prior treatment with statins and 3. a non significant lesion in one of the two non-culprit coronary arteries Exclusion Criteria: 1. age below 18 or above 81 years, 2. unconscious patients, 3. serum creatinine > 176µmol/L, 4. hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)), 5. current liver disease (ALAT > 2 x ULN), 6. unexplained creatine kinase > 3 x ULN, 7. alcohol or drug abuse within the last five years, 8. prior myopathy or serious hypersensitivity reaction caused by statins, 9. women with childbearing potential who were not using chemical or mechanical contraception, 10. pregnant or breastfeeding women, 11. history of malignancy unless a disease-free period of more than five years was present, 12. patients with abnormal lung function test (LFT), 13. participation in another investigational drug study less than four weeks before enrolment in the present study, 14. treatment with cyclosporine or fibrates |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Department of Cardiology, Odense University Hospital | Odense | Fuenen |
| Lead Sponsor | Collaborator |
|---|---|
| Odense University Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR). | One year | No | |
| Secondary | The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values. | One year | No |