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

NCT01203982 | Completed Phase 4 DMC

• 1 other identifier: VF-20060060
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ST-segment Elevation Myocardial Infarction; Subclinical Carotid Atherosclerosis

Keywords

CIMT; IVUS-VH; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• change from baseline in mean CIMT

  Average of the far wall of common and bulbus carotid artery

  baseline, 6month, 12 month

Secondary Outcomes (8)

• changes from baseline in max CIMT

  baseline, 6month, 12 month

• change from baseline in mean common CIMT

  baaseline, 6month 12 month

• change from baseline in max common CIMT

  baseline, 6month 12month

• change from baseline in mean bulbus CIMT

  Baseline, 6month 12 month

• change from baseline in max bulbus CIMT

  baseline, 6month 12month

Study Arms (2)

Rosuvastatin 5mg

ACTIVE COMPARATOR

Rosuvastatin 5mg/day

Drug: Rosuvastatin

Rosuvastatin 40mg

ACTIVE COMPARATOR

Rosuvastatin 40mg/day

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Rosuvastatin 5mg/day for one year

Also known as: Crestor

Rosuvastatin 5mg

Eligibility Criteria

• Age: 18 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI,
• no prior treatment with statins and
• a non significant lesion in one of the two non-culprit coronary arteries. -

You may not qualify if:

• age below 18 or above 81 years,
• unconscious patients,
• serum creatinine \> 176μmol/L,
• total-cholesterol \> 7.0 mmol/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,
• history of malignancy unless a disease-free period of more than five years was present,
• patients with abnormal lung function test (LFT),
• participation in another investigational drug study less than four weeks before enrolment in the present study,
• treatment with cyclosporine or fibrates. -

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Cardiology, Odense University Hospital

Odense, Fuenen, 5000, Denmark

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Coronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: November 1, 2007
• Study Completion: June 1, 2009
• Last Updated: September 17, 2010

Record last verified: 2010-09

Locations

DK (1)