Myocardial InfarctionPhase 4NCT01205347
Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
A Phase 4 study testing Simvastatin 80mg and Simvastatin 10mg in people with Myocardial Infarction, run by Brasilia Heart Study Group at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Simvastatin 80mg and Simvastatin 10mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2010to Sep 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes or prior use of statins in the last 6 months
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Base do Distrito Federal
Brasília, Federal District, 70000.000
About this study
Official title: Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
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.
Read the detailed description
Stress hyperglycemia during myocardial infarction (MI) is a predictor of worse prognosis at short and long term. From the mechanistic standpoint, hyperglycemia can attenuate thrombolysis, increase platelet aggregation, induce coronary vasoconstriction, reduce oxygen transport and prolong endothelial inflammation after MI. Consistently, observational data indicates that glucose normalization improves survival in hyperglycemic patients hospitalized with MI.
High dose potent statins have been included in the early treatment of acute coronary syndromes (ACS) based upon a broad range of potentially beneficial mechanisms. Recent studies, however, revealed that chronic statin treatment may increase the incidence of type 2 diabetes mellitus in a dose-dependent manner. Moreover, according to studies in cellular and animal models, such decrease in insulin sensitivity may be observed immediately after statin therapy initiation. By inference, one may speculate that statin treatment initiated at the acute phase of MI may potentially favor the appearance or aggravation of stress hyperglycemia. To date, however, this hypothesis has not been investigated. Hence, this study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.
- Conditions
- Myocardial Infarction
- Being tested
- Simvastatin 80mg, Simvastatin 10mg
- Keywords
- Statin, Myocardial infarction, Insulin sensitivity
- Medical subject headings
- Myocardial Infarction, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 80mgDrug
Also called Zocor
Simvastatin 80mg once a day
Simvastatin 10mgDrug
Also called Zocor
Simvastatin 10mg once a day
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin 80mg | Experimental | Simvastatin 80mg once a day Receives: Drug: Simvastatin 80mg |
| Simvastatin 10mg | Active comparator | Simvastatin 10mg once a day Receives: Drug: Simvastatin 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
Measured: 5 days
Secondary outcomes (1)
Activation of insulin receptor substrate (IRS-1) and Akt protein
Verify the degree of phosphorylation of insulin receptor substrate (IRS-1) and Akt protein estimated by Western Blotting of the abdominal adipose tissue obtained by biopsy
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia Heart Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei C. Sposito, Brasilia Heart Study Group
- Investigators
- Andrei C Sposito, MD PhD, Study chair, Faculty of Medical Sciences, State University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205347
- Sponsor's protocol ID
- Statin_InsulinSensitivity
- Status last verified
- Sep 2013
- First submitted
- 17 Sep 2010
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of the Effect of Statin Treatment on Insulin Sensitivity During Myocardial Infarction
- ClinicalTrials.gov ID
- NCT01205347
- Acronym / sponsor ID
- Statin_InsulinSensitivity
- Conditions
- Myocardial Infarction
- Keywords
- Statin, Myocardial infarction, Insulin sensitivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Brasilia Heart Study GroupUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stress hyperglycemia during myocardial infarction (MI) is a predictor of worse prognosis at short and long term. From the mechanistic standpoint, hyperglycemia can attenuate thrombolysis, increase platelet aggregation, induce coronary vasoconstriction, reduce oxygen transport and prolong endothelial inflammation after MI. Consistently, observational data indicates that glucose normalization improves survival in hyperglycemic patients hospitalized with MI.
High dose potent statins have been included in the early treatment of acute coronary syndromes (ACS) based upon a broad range of potentially beneficial mechanisms. Recent studies, however, revealed that chronic statin treatment may increase the incidence of type 2 diabetes mellitus in a dose-dependent manner. Moreover, according to studies in cellular and animal models, such decrease in insulin sensitivity may be observed immediately after statin therapy initiation. By inference, one may speculate that statin treatment initiated at the acute phase of MI may potentially favor the appearance or aggravation of stress hyperglycemia. To date, however, this hypothesis has not been investigated. Hence, this study aim was to investigate the dose-dependent effect of statins on insulin sensitivity in patients in the acute phase of MI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin 80mg | Experimental | Drug: Simvastatin 80mgSimvastatin 80mg once a day |
| Simvastatin 10mg | Active comparator | Drug: Simvastatin 10mgSimvastatin 10mg once a day |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Diabetes or prior use of statins in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simvastatin 80mgAlso: ZocorSimvastatin 80mg once a day | Drug | Simvastatin 80mg |
| Simvastatin 10mgAlso: ZocorSimvastatin 10mg once a day | Drug | Simvastatin 10mg |
Primary outcome
Insulin sensitivity
Time frame: 5 days
Insulin sensitivity as determined by hyperinsulinemic normoglycemic clamp
1 secondary outcome
Activation of insulin receptor substrate (IRS-1) and Akt protein
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei C Sposito, MD PhD study chair
Faculty of Medical Sciences, State University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin 80mg and Simvastatin 10mg in people with Myocardial Infarction, run by Brasilia Heart Study Group at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.