Myocardial Infarction [C14.907.585.500]Phase 4NCT01245894
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment
A Phase 4 study testing Low-dose Rosuvastatin and High-dose Rosuvastatin in people with Myocardial Infarction [C14.907.585.500], run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Myocardial Infarction [C14.907.585.500]
- What is being tested?
- Low-dose Rosuvastatin and High-dose 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 2010
- 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
- ST-segment elevation myocardial infarction
- 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,
- hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)),
- current liver disease (ALAT > 2 x ULN),
- unexplained creatine kinase > 3 x ULN,
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- 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 the Coronary Microcirculation
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.
- Conditions
- Myocardial Infarction [C14.907.585.500]
- Being tested
- Low-dose Rosuvastatin, High-dose Rosuvastatin
- Keywords
- Index of microcirculatory resistance, Fractional Flow Reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose RosuvastatinDrug
Also called Crestor
Rosuvastatin 5mg/day for one year
High-dose RosuvastatinDrug
Also called Crestor
Rosuvastatin 40mg/day for one year
| Study group | Role | What they receive |
|---|---|---|
| Low-dose Rosuvastatin | Active comparator | 5mg Rosuvastatin/day Receives: Drug: Low-dose Rosuvastatin |
| High-dose Rosuvastatin | Active comparator | Rosuvastatin 40mg/day Receives: Drug: High-dose Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Measured: One year
Secondary outcomes (1)
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
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 posted23 Nov 2010 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction [C14.907.585.500]Studies 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
- Investigators
- Rasmus Egede, MD, Principal investigator, Department of Cardiology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245894
- Sponsor's protocol ID
- VF-20060
- Status last verified
- Nov 2007
- First submitted
- 22 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 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 the Coronary Microcirculation
- ClinicalTrials.gov ID
- NCT01245894
- Acronym / sponsor ID
- VF-20060
- Conditions
- Myocardial Infarction [C14.907.585.500]
- Keywords
- Index of microcirculatory resistance, Fractional Flow Reserve
- 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
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 23 Nov 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 low- and high-dose lipid-lowering treatment with rosuvastatin on the coronary physiology parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dose Rosuvastatin | Active comparator | Drug: Low-dose Rosuvastatin5mg Rosuvastatin/day |
| High-dose Rosuvastatin | Active comparator | Drug: High-dose 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)
- ST-segment elevation myocardial infarction
- no prior treatment with statins and
- a non significant lesion in one of the two non-culprit coronary arteries
Key exclusion criteria (14 listed)
- 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),
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 |
|---|---|---|
| Low-dose RosuvastatinAlso: CrestorRosuvastatin 5mg/day for one year | Drug | Low-dose Rosuvastatin |
| High-dose RosuvastatinAlso: CrestorRosuvastatin 40mg/day for one year | Drug | High-dose Rosuvastatin |
Primary outcome
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR).
Time frame: One year
1 secondary outcome
The secondary endpoints were the changes from baseline in Fractional Flow Reserve (FFR) and lipid values.
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 23 Nov 2010.
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 Phase 4 study testing Low-dose Rosuvastatin and High-dose Rosuvastatin in people with Myocardial Infarction [C14.907.585.500], 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 14 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 23 Nov 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?
The primary endpoint was the change from baseline in Index of microcirculatory resistance(IMR). (time frame: One year). 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 23 Nov 2010.