Effect of Intensive Lipid Lowering Treatment Compared to... | NCT01223625

Studies
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

NCT01223625

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Oct 19, 2010Estimated

Enrollment

87Actual

Phase

Phase 4

Conditions

Endothelial Dysfunction
Atherosclerosis

Interventions

Rosuvastatin 5mg/day
Rosuvastatin 40mg/day

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2010Actual

First Submitted Date

Oct 18, 2010

First Submission Date that Met QC Criteria

Oct 18, 2010

First Posted Date

Oct 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2010

Last Update Posted Date

Oct 19, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rosuvastatin 5mg/day	Active Comparator	Rosuvastatin 5mg/day	Drug: Rosuvastatin 5mg/day
Rosuvastatin 40mg/day	Active Comparator	Rosuvastatin 40mg/day	Drug: Rosuvastatin 40mg/day

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rosuvastatin 5mg/day	Drug	Rosuvastatin 5mg/day	Rosuvastatin 5mg/day

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.		One year

Secondary Outcomes

Measure	Description	Time Frame
The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery		One Year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

STEMI
no prior treatment with statins

Exclusion Criteria:

age below 18 or above 81 years
unconscious patients
serum creatinine > 176μmol/L
total-cholesterol > 7.0 mmol/l
hypothyreoidism ((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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rasmus Egede, MD	Department of Cardiology, Odense University Hospital, Odense, Denmark.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Cardiology, Odense University Hospital		Odense	Fuenen	5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21349594	Derived	Egede R, Jensen LO, Hansen HS, Antonsen L, Hansen KN, Junker A, Thayssen P. Effect of intensive lipid-lowering treatment compared to moderate lipid-lowering treatment with rosuvastatin on endothelial function in high risk patients. Int J Cardiol. 2012 Jul 26;158(3):376-9. doi: 10.1016/j.ijcard.2011.01.071. Epub 2011 Feb 23.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes