Influence of Intensive Lipid Lowering Treatment Compared... | NCT01245894

Studies
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment

NCT01245894

Sponsor

Odense University Hospital

Status

Completed

Last Update Posted

Nov 23, 2010Estimated

Enrollment

87Actual

Phase

Phase 4

Conditions

Myocardial Infarction [C14.907.585.500]

Interventions

Low-dose Rosuvastatin
High-dose Rosuvastatin

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

Nov 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

Nov 22, 2010

First Submission Date that Met QC Criteria

Nov 22, 2010

First Posted Date

Nov 23, 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

Nov 22, 2010

Last Update Posted Date

Nov 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.

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
Low-dose Rosuvastatin	Active Comparator	5mg Rosuvastatin/day	Drug: Low-dose Rosuvastatin
High-dose Rosuvastatin	Active Comparator	Rosuvastatin 40mg/day	Drug: High-dose Rosuvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low-dose Rosuvastatin	Drug	Rosuvastatin 5mg/day for one year	Low-dose Rosuvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).		One year

Secondary Outcomes

Measure	Description	Time Frame
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.		One year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ST-segment elevation myocardial infarction
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,
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

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	Principal Investigator

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D000068718	Rosuvastatin Calcium

Ancestor Terms

ID	Term
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D005464	Fluorobenzenes

Browse Leaves

Not provided

Browse Branches

Not provided