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Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01203982
First received: September 15, 2010
Last updated: September 16, 2010
Last verified: September 2010
History of Changes
  Purpose

The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate marker of cardiovascular risk.


Condition Intervention Phase
ST-segment Elevation Myocardial Infarction
Subclinical Carotid Atherosclerosis
 Drug: Rosuvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima Media Thickness and Its Relation to Plaque Components of the Coronary Arteries in Patients With ST-Segment Elevation Acute Myocardial Infarction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • change from baseline in mean CIMT [ Time Frame: baseline, 6month, 12 month ] [ Designated as safety issue: No ]
    Average of the far wall of common and bulbus carotid artery


Secondary Outcome Measures:
  • changes from baseline in max CIMT [ Time Frame: baseline, 6month, 12 month ] [ Designated as safety issue: No ]
  • change from baseline in mean common CIMT [ Time Frame: baaseline, 6month 12 month ] [ Designated as safety issue: No ]
  • change from baseline in max common CIMT [ Time Frame: baseline, 6month 12month ] [ Designated as safety issue: No ]
  • change from baseline in mean bulbus CIMT [ Time Frame: Baseline, 6month 12 month ] [ Designated as safety issue: No ]
  • change from baseline in max bulbus CIMT [ Time Frame: baseline, 6month 12month ] [ Designated as safety issue: No ]
  • change from baseline in lipid values [ Time Frame: baseline, 6month 12month ] [ Designated as safety issue: No ]
  • correlation between CIMT measurements and lipid values [ Time Frame: Baseline, 6month 12 month ] [ Designated as safety issue: No ]
  • correlation between CIMT measurements and plaque components evaluated by IVUS-VH [ Time Frame: Baseline, 6month 12month ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: November 2007
Study Completion Date: June 2009
Arms Assigned Interventions
Active Comparator: Rosuvastatin 5mg
Rosuvastatin 5mg/day
 Drug: Rosuvastatin
Rosuvastatin 5mg/day for one year
Other Name: Crestor
Active Comparator: Rosuvastatin 40mg
Rosuvastatin 40mg/day
 Drug: Rosuvastatin
Rosuvastatin 40mg/day for one year
Other Name: Crestor

Detailed Description:

The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg) lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a surrogate marker of cardiovascular risk and to obtain whether CIMT correlated with the plaque components in coronary arteries evaluated with Intravascular Ultrasound Virtual Histology (IVUS-VH).

  Eligibility

Ages Eligible for Study:   18 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. STEMI,
  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. total-cholesterol > 7.0 mmol/l,
  5. hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
  6. current liver disease (ALAT > 2 x ULN),
  7. unexplained creatine kinase > 3 x ULN,
  8. alcohol or drug abuse within the last five years,
  9. prior myopathy or serious hypersensitivity reaction caused by statins,
  10. women with childbearing potential who were not using chemical or mechanical contraception,
  11. pregnant or breastfeeding women,
  12. history of malignancy unless a disease-free period of more than five years was present,
  13. patients with abnormal lung function test (LFT),
  14. participation in another investigational drug study less than four weeks before enrolment in the present study,
  15. treatment with cyclosporine or fibrates. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203982

Locations
Denmark
Department of Cardiology, Odense University Hospital
Odense, Fuenen, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
  More Information

No publications provided

Responsible Party: Rasmus Egede, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01203982     History of Changes
Other Study ID Numbers: VF-20060060
Study First Received: September 15, 2010
Last Updated: September 16, 2010
Health Authority: Denmark: GCP-department of Odense University Hospital and the Danish Medicines Agency

Keywords provided by Odense University Hospital:
CIMT
IVUS-VH
Coronary artery disease

Additional relevant MeSH terms:
Atherosclerosis
Infarction
Myocardial Infarction
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013