NCT01205347

Brief Summary

Stress hyperglycemia during myocardial infarction (MI) is related to mortality at short and long term. Recent studies, however, revealed that chronic statin treatment may decrease both insulin sensitivity and secretion immediately after statin therapy initiation. This study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

September 17, 2010

Last Update Submit

September 8, 2013

Conditions

Myocardial Infarction

Keywords

StatinMyocardial infarctionInsulin sensitivity

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp

    5 days

Secondary Outcomes (1)

  • Activation of insulin receptor substrate (IRS-1) and Akt protein

    5 days

Study Arms (2)

Simvastatin 80mg

EXPERIMENTAL

Simvastatin 80mg once a day

Drug: Simvastatin 80mg

Simvastatin 10mg

ACTIVE COMPARATOR

Simvastatin 10mg once a day

Drug: Simvastatin 10mg

Interventions

Simvastatin 80mgDRUG

Simvastatin 80mg once a day

Also known as: Zocor
Simvastatin 80mg
Simvastatin 10mgDRUG

Simvastatin 10mg once a day

Also known as: Zocor
Simvastatin 10mg

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Less than 24 hours after the onset of MI symptoms
  • ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads
  • Myocardial necrosis, as evidenced by increased Creatine Kinase-MB (CK-MB) and troponin levels

You may not qualify if:

  • Diabetes or prior use of statins in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70000.000, Brazil

Location

MeSH Terms

Conditions

Myocardial InfarctionInsulin Resistance

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Andrei C Sposito, MD PhD

    Faculty of Medical Sciences, State University of Campinas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 20, 2010

Study Start

October 1, 2010

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

BR(1)