HealthyPhase 4NCT02533141
Effect of Simvastatin Withdrawal on Ocular Endothelial Function
A Phase 4 study testing Dynamic Vessel Analyzer (DVA), Laser Doppler Velocimetry (LDV) and Simvastatin in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Statins are drugs representing the most commonly prescribed medication for the treatment of hypercholesterolemia. In a recently published study, discontinuation of statin therapy in patients after acute myocardial infarction was associated with a higher all-cause mortality (hazard ratio 3,45) and a higher cardiac… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dynamic Vessel Analyzer (DVA), Laser Doppler Velocimetry (LDV) and Simvastatin
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2019to Dec 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Informed consent for participation
- Men and women aged between 18 and 45 years, non-smokers
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
- Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg
- Normal ophthalmic findings, ametropia less than 6 diopters
Who cannot join
- History or presence of ocular disease
- Ametropy ≥ 6 dpt
- Previous or current treatment with statins
- Treatment with any drug in the 3 weeks preceding the first study day
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
- Participation in a clinical trial in the 3 weeks preceding the first study day
Show all 12Show fewer
- Blood donation during the 3 weeks preceding the first study day
- History or family history of epilepsy
- History or presence of myopathy, renal failure or elevation of creatine kinase (CK) above normal levels
- History or presence of hepatic dysfunction, including increase of liver enzymes
- Abuse of alcoholic beverages
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Statins are drugs representing the most commonly prescribed medication for the treatment of hypercholesterolemia. In a recently published study, discontinuation of statin therapy in patients after acute myocardial infarction was associated with a higher all-cause mortality (hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence suggests that statins also have vasoactive properties by up-regulating endothelial nitric oxide synthase (eNOS) with positive effects on endothelial function. Experiments with flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on endothelial function but also revealed that withdrawal of statin treatment transiently worsens endothelial function, independently of serum cholesterol levels.
Consequently, this placebo controlled Phase IV crossover study wants to assess changes of endothelial function in terms of flicker induced vasodilatation before and during statin therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced vasodilatation and retinal oxygen saturation will be measured with the Dynamic Vessel Analyzer system by Imedos at baseline, in the 4th week of simvastatin or placebo intake as well as 3, 7 and 14 days after the end of intake.
- Conditions
- Healthy
- Being tested
- Dynamic Vessel Analyzer (DVA), Laser Doppler Velocimetry (LDV), Simvastatin, Placebo
- Keywords
- Investigation of the changes of flicker induced vasodilatation before, during and after withdrawal of therapy with simvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Vessel Analyzer (DVA)Device
Measurement of flicker induced vasodilatation, retinal vessel diameters and oxygen saturation
Laser Doppler Velocimetry (LDV)Device
Measurement of red blood cell velocity in retinal vessels
SimvastatinDrug
Simvastatin Ranbaxy (Basics GmbH, Leverkusen, Germany) Dosage: 40 mg per day for 4 weeks, ingested in the morning Route of administration: peroral
PlaceboOther
Placebo, once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 10 healthy subjects receiving at first simvastatin for 4 weeks, then crossover. Measurements will be done with the Dynamic Vessel Analyzer (DVA) and Laser Doppler Velocimetry (LDV). Receives: Device: Dynamic Vessel Analyzer (DVA); Device: Laser Doppler Velocimetry (LDV); Drug: Simvastatin |
| Placebo group | Placebo comparator | 10 healthy subjects receiving at first placebo for 4 weeks, then crossover. Measurements will be done with the Dynamic Vessel Analyzer (DVA) and Laser Doppler Velocimetry (LDV). Receives: Device: Dynamic Vessel Analyzer (DVA); Device: Laser Doppler Velocimetry (LDV); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flicker induced vasodilatation (DVA)
Measured: 16 weeks
Secondary outcomes (2)
Retinal oxygen saturation (DVA)
Measured: 16 weeks
Red blood cell velocity (LDV)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startOct 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533141
- Sponsor's protocol ID
- OPHT-240215
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2015
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simvastatin Withdrawal on Ocular Endothelial Function
- ClinicalTrials.gov ID
- NCT02533141
- Acronym / sponsor ID
- OPHT-240215
- Conditions
- Healthy
- Keywords
- Investigation of the changes of flicker induced vasodilatation before, during and after withdrawal of therapy with simvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Aug 2015 (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.
Statins are drugs representing the most commonly prescribed medication for the treatment of hypercholesterolemia. In a recently published study, discontinuation of statin therapy in patients after acute myocardial infarction was associated with a higher all-cause mortality (hazard ratio 3,45) and a higher cardiac mortality (hazard ratio 4,65). Increasing evidence suggests that statins also have vasoactive properties by up-regulating endothelial nitric oxide synthase (eNOS) with positive effects on endothelial function. Experiments with flow-mediated vasodilatation (FMD) showed these positive effects of statin treatment on endothelial function but also revealed that withdrawal of statin treatment transiently worsens endothelial function, independently of serum cholesterol levels.
Consequently, this placebo controlled Phase IV crossover study wants to assess changes of endothelial function in terms of flicker induced vasodilatation before and during statin therapy as well as after statin withdrawal. For this purpose 20 healthy subjects will be treated with 40 mg/day of simvastatin for a period of 4 weeks. Flicker induced vasodilatation and retinal oxygen saturation will be measured with the Dynamic Vessel Analyzer system by Imedos at baseline, in the 4th week of simvastatin or placebo intake as well as 3, 7 and 14 days after the end of intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Dynamic Vessel Analyzer (DVA), Device: Laser Doppler Velocimetry (LDV), Drug: Simvastatin10 healthy subjects receiving at first simvastatin for 4 weeks, then crossover. Measurements will be done with the Dynamic Vessel Analyzer (DVA) and Laser Doppler Velocimetry (LDV). |
| Placebo group | Placebo comparator | Device: Dynamic Vessel Analyzer (DVA), Device: Laser Doppler Velocimetry (LDV), Other: Placebo10 healthy subjects receiving at first placebo for 4 weeks, then crossover. Measurements will be done with the Dynamic Vessel Analyzer (DVA) and Laser Doppler Velocimetry (LDV). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Informed consent for participation
- Men and women aged between 18 and 45 years, non-smokers
- Body mass index between 15th and 85th percentile
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
- Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Key exclusion criteria (12 listed)
- History or presence of ocular disease
- Ametropy ≥ 6 dpt
- Previous or current treatment with statins
- Treatment with any drug in the 3 weeks preceding the first study day
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day
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 |
|---|---|---|
| Dynamic Vessel Analyzer (DVA)Measurement of flicker induced vasodilatation, retinal vessel diameters and oxygen saturation | Device | Intervention group, Placebo group |
| Laser Doppler Velocimetry (LDV)Measurement of red blood cell velocity in retinal vessels | Device | Intervention group, Placebo group |
| SimvastatinSimvastatin Ranbaxy (Basics GmbH, Leverkusen, Germany) Dosage: 40 mg per day for 4 weeks, ingested in the morning Route of administration: peroral | Drug | Intervention group |
| PlaceboPlacebo, once daily for 4 weeks | Other | Placebo group |
Primary outcome
Flicker induced vasodilatation (DVA)
Time frame: 16 weeks
2 secondary outcomes
Retinal oxygen saturation (DVA)
Time frame: 16 weeks
Red blood cell velocity (LDV)
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
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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 Dynamic Vessel Analyzer (DVA), Laser Doppler Velocimetry (LDV) and Simvastatin in people with Healthy, run by Medical University of Vienna at 1 site in Austria.
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 7 inclusion and 12 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: withdrawn, as of the sponsor's last update on 20 Feb 2020. 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 Austria. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Flicker induced vasodilatation (DVA) (time frame: 16 weeks). 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 20 Feb 2020.