ST-segment Elevation Myocardial InfarctionPhase 4NCT01203982
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)
A Phase 4 study testing Rosuvastatin in people with ST-segment Elevation Myocardial Infarction and Subclinical Carotid Atherosclerosis, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction, Subclinical Carotid Atherosclerosis
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Jun 2009
- 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 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- STEMI,
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries. -
Who cannot join
- 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),
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- 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. -
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology, Odense University Hospital
Odense, Fuenen, 5000
About this study
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
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.
Read the 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).
- Being tested
- Rosuvastatin
- Keywords
- CIMT, IVUS-VH, Coronary artery disease
- Medical subject headings
- ST Elevation Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Also called Crestor
Rosuvastatin 5mg/day for one year
RosuvastatinDrug
Also called Crestor
Rosuvastatin 40mg/day for one year
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 5mg | Active comparator | Rosuvastatin 5mg/day Receives: Drug: Rosuvastatin |
| Rosuvastatin 40mg | Active comparator | Rosuvastatin 40mg/day Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in mean CIMT
Average of the far wall of common and bulbus carotid artery
Measured: baseline, 6month, 12 month
Secondary outcomes (8)
changes from baseline in max CIMT
Measured: baseline, 6month, 12 month
change from baseline in mean common CIMT
Measured: baaseline, 6month 12 month
change from baseline in max common CIMT
Measured: baseline, 6month 12month
change from baseline in mean bulbus CIMT
Measured: Baseline, 6month 12 month
change from baseline in max bulbus CIMT
Measured: baseline, 6month 12month
change from baseline in lipid values
Measured: baseline, 6month 12month
correlation between CIMT measurements and lipid values
Measured: Baseline, 6month 12 month
correlation between CIMT measurements and plaque components evaluated by IVUS-VH
Measured: Baseline, 6month 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startNov 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203982
- Sponsor's protocol ID
- VF-20060060
- Status last verified
- Sep 2010
- First submitted
- 15 Sep 2010
- Last updated
- 17 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01203982
- Acronym / sponsor ID
- VF-20060060
- Keywords
- CIMT, IVUS-VH, Coronary artery disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Study completion
- Jun 2009 (actual)
- First posted
- 17 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin 5mg | Active comparator | Drug: RosuvastatinRosuvastatin 5mg/day |
| Rosuvastatin 40mg | Active comparator | Drug: RosuvastatinRosuvastatin 40mg/day |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- STEMI,
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries. -
Key exclusion criteria (15 listed)
- 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)),
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 |
|---|---|---|
| RosuvastatinAlso: CrestorRosuvastatin 5mg/day for one year | Drug | Rosuvastatin 5mg |
| RosuvastatinAlso: CrestorRosuvastatin 40mg/day for one year | Drug | Rosuvastatin 40mg |
Primary outcome
change from baseline in mean CIMT
Time frame: baseline, 6month, 12 month
Average of the far wall of common and bulbus carotid artery
8 secondary outcomes
changes from baseline in max CIMT
Time frame: baseline, 6month, 12 month
change from baseline in mean common CIMT
Time frame: baaseline, 6month 12 month
change from baseline in max common CIMT
Time frame: baseline, 6month 12month
change from baseline in mean bulbus CIMT
Time frame: Baseline, 6month 12 month
change from baseline in max bulbus CIMT
Time frame: baseline, 6month 12month
change from baseline in lipid values
Time frame: baseline, 6month 12month
correlation between CIMT measurements and lipid values
Time frame: Baseline, 6month 12 month
correlation between CIMT measurements and plaque components evaluated by IVUS-VH
Time frame: Baseline, 6month 12month
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 17 Sep 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rosuvastatin in people with ST-segment Elevation Myocardial Infarction and Subclinical Carotid Atherosclerosis, run by Odense University Hospital at 1 site in Denmark.
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 15 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 17 Sep 2010. 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 Denmark. 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?
change from baseline in mean CIMT (time frame: baseline, 6month, 12 month). 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 17 Sep 2010.