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

ST-segment Elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203982
• Other study ID #: VF-20060060
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: September 16, 2010
• Start date: November 2007
• Est. completion date: June 2009

Study information

• Verified date: September 2010
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: GCP-department of Odense University Hospital and the Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 81 Years

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction
• Subclinical Carotid Atherosclerosis

Intervention

Drug:
• Rosuvastatin
Rosuvastatin 5mg/day for one year
• Rosuvastatin
Rosuvastatin 40mg/day for one year

Locations

Country	Name	City	State
Denmark	Department of Cardiology, Odense University Hospital	Odense	Fuenen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline in mean CIMT	Average of the far wall of common and bulbus carotid artery	baseline, 6month, 12 month	No
Secondary	changes from baseline in max CIMT		baseline, 6month, 12 month	No
Secondary	change from baseline in mean common CIMT		baaseline, 6month 12 month	No
Secondary	change from baseline in max common CIMT		baseline, 6month 12month	No
Secondary	change from baseline in mean bulbus CIMT		Baseline, 6month 12 month	No
Secondary	change from baseline in max bulbus CIMT		baseline, 6month 12month	No
Secondary	change from baseline in lipid values		baseline, 6month 12month	No
Secondary	correlation between CIMT measurements and lipid values		Baseline, 6month 12 month	No
Secondary	correlation between CIMT measurements and plaque components evaluated by IVUS-VH		Baseline, 6month 12month	No