Acute Coronary SyndromeVIRHISTAMINCT01058915
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)
A study testing Rosuvastatin 5mg and Rosuvastatin 40mg in people with Acute Coronary Syndrome, run by Odense University Hospital at 1 site in Denmark.
Trial summary
In patients with ST-segment elevation acute myocardial infarction (STEMI) increased LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate LDL-cholesterol reduction (rosuvastatin 5… Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Rosuvastatin 5mg and Rosuvastatin 40mg
- 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
- Interventional
- 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
- ST segment elevation acute myocardial infarction
- 20% < angiographic diameter stenosis < 50% on a not previously revascularized native coronary artery
- Statin naïve
Who cannot join
- Pharmacologic lipid lowering treatment before index hospitalization
- Atrial fibrillation, not well rate-controlled
- Ventricle frequency variation with more than a factor 2 over 1 minute
- Unconscious patients
- Total cholesterol > 7.0 mmol/l
- History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins) including rosuvastatin
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- Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin [Beta-HCG] analysis)
- History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin, or in the case of a study designed to investigate antineoplastic properties of rosuvastatin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears
- Uncontrolled hypothyroidism (TSH > 1.5xULN)
- Abnormal LFT's
- History of alcohol or drug abuse within the last 5 years (this may affect compliance)
- Current active liver disease (ALT/SGPT >2xULN or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins)
- Unexplained creatine kinase (CK > 3xULN) (To protect patient safety) (will be increased at baseline because of acute ST segment elevation myocardial infarction a few days before enrolment)
- Serum creatinine >176mmol/L (2.0mg/dL) (unless the protocol specifically aims to investigate a chronic renal disease population)
- Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events)
- Treatments with cyclosporine
- Treatment with gemfibrozil
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: Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition Assessed by Virtual Histology in Patients With ST-Segment Elevation Acute Myocardial Infarction (VIRHISTAMI)
In patients with ST-segment elevation acute myocardial infarction (STEMI) increased LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).
- Conditions
- Acute Coronary Syndrome
- Being tested
- Rosuvastatin 5mg, Rosuvastatin 40mg
- Keywords
- ST-Segment Elevation Myocardial Infarction
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 5mgDrug
Also called Crestor
Rosuvastatin 5mg/day
Rosuvastatin 40mgDrug
Also called Crestor
Rosuvastatin 40mg/day
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin 5mg | Active comparator | Rosuvastatin 5mg/day for one year Receives: Drug: Rosuvastatin 5mg |
| Rosuvaststin 40mg | Active comparator | Rosuvastatin 40mg/day Receives: Drug: Rosuvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline).
Measured: One year
Secondary outcomes (1)
Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2010 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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 N/A
- 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
- Investigators
- Rasmus Egede, MD, Principal investigator, Department of Cardiology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058915
- Sponsor's protocol ID
- 2006-003111-43
- Acronym
- VIRHISTAMI
- Status last verified
- Jan 2010
- First submitted
- 28 Jan 2010
- Last updated
- 29 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Nair A, Kuban BD, Tuzcu EM, Schoenhagen P, Nissen SE, Vince DG. Coronary plaque classification with intravascular ultrasound radiofrequency data analysis. Circulation. 2002 Oct 22;106(17):2200-6. doi: 10.1161/01.cir.0000035654.18341.5e.
PubMed 12390948Jensen LO, Thayssen P, Pedersen KE, Stender S, Haghfelt T. Regression of coronary atherosclerosis by simvastatin: a serial intravascular ultrasound study. Circulation. 2004 Jul 20;110(3):265-70. doi: 10.1161/01.CIR.0000135215.75876.41. Epub 2004 Jul 6.
PubMed 15238460Egede R, Jensen LO, Hansen HS, Hansen KN, Junker A, Thayssen P. Influence of high-dose lipid lowering treatment compared to low-dose lipid lowering treatment on plaque composition assessed by intravascular ultrasound virtual histology in patients with ST-segment elevation acute myocardial infarction: the VIRHISTAMI trial. EuroIntervention. 2013 Feb 22;8(10):1182-9. doi: 10.4244/EIJV8I10A182.
PubMed 22987572
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition Assessed by Virtual Histology in Patients With ST-Segment Elevation Acute Myocardial Infarction (VIRHISTAMI)
- ClinicalTrials.gov ID
- NCT01058915
- Acronym / sponsor ID
- VIRHISTAMI / 2006-003111-43
- Conditions
- Acute Coronary Syndrome
- Keywords
- ST-Segment Elevation Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jan 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.
In patients with ST-segment elevation acute myocardial infarction (STEMI) increased LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and 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: Rosuvastatin 5mgRosuvastatin 5mg/day for one year |
| Rosuvaststin 40mg | Active comparator | Drug: Rosuvastatin 40mgRosuvastatin 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)
- ST segment elevation acute myocardial infarction
- 20% < angiographic diameter stenosis < 50% on a not previously revascularized native coronary artery
- Statin naïve
Key exclusion criteria (17 listed)
- Pharmacologic lipid lowering treatment before index hospitalization
- Atrial fibrillation, not well rate-controlled
- Ventricle frequency variation with more than a factor 2 over 1 minute
- Unconscious patients
- Total cholesterol > 7.0 mmol/l
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 |
|---|---|---|
| Rosuvastatin 5mgAlso: CrestorRosuvastatin 5mg/day | Drug | Rosuvastatin 5mg |
| Rosuvastatin 40mgAlso: CrestorRosuvastatin 40mg/day | Drug | Rosuvaststin 40mg |
Primary outcome
Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline).
Time frame: One year
1 secondary outcome
Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline).
Time frame: One year
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 29 Jan 2010.
- Background: PubMed 12390948Nair A, Kuban BD, Tuzcu EM, Schoenhagen P, Nissen SE, Vince DG. Coronary plaque classification with intravascular ultrasound radiofrequency data analysis. Circulation. 2002 Oct 22;106(17):2200-6. doi: 10.1161/01.cir.0000035654.18341.5e.
- Background: PubMed 15238460Jensen LO, Thayssen P, Pedersen KE, Stender S, Haghfelt T. Regression of coronary atherosclerosis by simvastatin: a serial intravascular ultrasound study. Circulation. 2004 Jul 20;110(3):265-70. doi: 10.1161/01.CIR.0000135215.75876.41. Epub 2004 Jul 6.
- Derived from this study: PubMed 22987572Egede R, Jensen LO, Hansen HS, Hansen KN, Junker A, Thayssen P. Influence of high-dose lipid lowering treatment compared to low-dose lipid lowering treatment on plaque composition assessed by intravascular ultrasound virtual histology in patients with ST-segment elevation acute myocardial infarction: the VIRHISTAMI trial. EuroIntervention. 2013 Feb 22;8(10):1182-9. doi: 10.4244/EIJV8I10A182.
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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.
Rasmus Egede, MD principal investigator
Department of Cardiology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin 5mg and Rosuvastatin 40mg in people with Acute Coronary Syndrome, 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 17 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 29 Jan 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.
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?
Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline). (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058915, which also lists 3 linked publications.
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 29 Jan 2010.