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

Primary Purpose

ST-segment Elevation Myocardial Infarction, Subclinical Carotid Atherosclerosis

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Rosuvastatin

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction focused on measuring CIMT, IVUS-VH, Coronary artery disease

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

STEMI,
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,
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. -

Sites / Locations

Department of Cardiology, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rosuvastatin 5mg

Rosuvastatin 40mg

Arm Description

Rosuvastatin 5mg/day

Rosuvastatin 40mg/day

Outcomes

Primary Outcome Measures

change from baseline in mean CIMT

Average of the far wall of common and bulbus carotid artery

Secondary Outcome Measures

changes from baseline in max CIMT

change from baseline in mean common CIMT

change from baseline in max common CIMT

change from baseline in mean bulbus CIMT

change from baseline in max bulbus CIMT

change from baseline in lipid values

correlation between CIMT measurements and lipid values

correlation between CIMT measurements and plaque components evaluated by IVUS-VH

Full Information

NCT ID

NCT01203982

First Posted

September 15, 2010

Last Updated

September 16, 2010

Sponsor

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01203982

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2010

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Odense University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST-segment Elevation Myocardial Infarction, Subclinical Carotid Atherosclerosis

Keywords

CIMT, IVUS-VH, Coronary artery disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rosuvastatin 5mg

Arm Type

Active Comparator

Arm Description

Rosuvastatin 5mg/day

Arm Title

Rosuvastatin 40mg

Arm Type

Active Comparator

Arm Description

Rosuvastatin 40mg/day

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Crestor

Intervention Description

Rosuvastatin 5mg/day for one year

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Other Intervention Name(s)

Crestor

Intervention Description

Rosuvastatin 40mg/day for one year

Primary Outcome Measure Information:

Title

change from baseline in mean CIMT

Description

Average of the far wall of common and bulbus carotid artery

Time Frame

baseline, 6month, 12 month

Secondary Outcome Measure Information:

Title

changes from baseline in max CIMT

Time Frame

baseline, 6month, 12 month

Title

change from baseline in mean common CIMT

Time Frame

baaseline, 6month 12 month

Title

change from baseline in max common CIMT

Time Frame

baseline, 6month 12month

Title

change from baseline in mean bulbus CIMT

Time Frame

Baseline, 6month 12 month

Title

change from baseline in max bulbus CIMT

Time Frame

baseline, 6month 12month

Title

change from baseline in lipid values

Time Frame

baseline, 6month 12month

Title

correlation between CIMT measurements and lipid values

Time Frame

Baseline, 6month 12 month

Title

correlation between CIMT measurements and plaque components evaluated by IVUS-VH

Time Frame

Baseline, 6month 12month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

81 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: STEMI, 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, 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. -

Facility Information:

Facility Name

Department of Cardiology, Odense University Hospital

City

Odense

State/Province

Fuenen

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

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

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