Blood Platelets ProteomePhase 2LovaCNCT02389868
Effects of Lovastatin on Human Platelet Proteome
A Phase 2 study testing Lovastatin in people with Blood Platelets Proteome, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize the cell signalling modifications induced by Lovastatin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Platelets Proteome
- What is being tested?
- Lovastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Jun 2015
- Phase
- Phase 2
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being an individual age 18 to 40.
- If applicable, female participants susceptible of becoming pregnant consent to use a highly efficient contraception technique AND an efficient contraception technique during the clinical trial and at least 3 months following ending the consumption of Lovastatin.
- Being able to read and understand French.
Who cannot join
- Having a known history of dyslipidemia.
- In regard of the lipid profile at the first visit, patients that are not comprised between the 5th and the 95th percentile for LDL, HDL or Total cholesterol will be excluded.
- Having a history of hypersensitivity to Lovastatin, to one of the components of this product or to any other statin.
- Being affected by mental retardation.
- Pregnancy or suspicion of pregnancy.
- Having an excessive alcohol consumption (a maximum of 3 drinks a day during the trial will be accepted).
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- Planning to perform unusual and very intense physical exercises during the study (ex: running a marathon or an Iron Man).
- Having a history of myopathy, myalgia or elevated creatine kinase (CK).
- In regard of the biochemical tests performed at the first visit, individuals having CK levels three times (or more) superior to the upper normal limit will be excluded.
- Having a personal or family history of hereditary muscular diseases.
- Having a history of renal or hepatic pathology.
- Taking one of the following drugs : any hypolipemic drug, any cytochrome P450 isoform 3A4 inhibitor (itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, erythromycin, clarithromycin, telithromycin, nefazodone and products containing cobicistat), ACE inhibitors, danazol, verapamil, diltiazem, cyclosporin, amiodarone, colchicine, fusidic acid (IV or oral).
- Having a history of hypothyroidism.
- Having had a surgical intervention shortly before the beginning of the clinical trial.
- Suffering from any other acute medical condition.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims to characterize the biological and inter-individual variation of platelet's proteome as measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of changes induced by Lovastatin on the platelet's proteome may allow the discovery of modifications relative to the effects of statins on hemostasis and the lipid profile.
- Conditions
- Blood Platelets Proteome
- Being tested
- Lovastatin
- Keywords
- Lovastatin, Proteome, Blood platelets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LovastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Lovastatin | Experimental | Not described Receives: Drug: Lovastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Signal Intensity Measured for Each Protein Identified by Mass Spectrometry in Blood Platelets Lysates
Proteins from total platelets lysates will be analyzed by TripleTOF 5600 LC-MS/MS (AB SCIEX). The intensity measured for each identified protein will be recorded in SWATH mode. Intensities measured for each protein before (baseline) and after treatment with lovastatin (at 6 weeks) will be recorded and compared.
Measured: Change from Baseline Protein Level at 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Platelets ProteomeStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathieu Fradet, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389868
- Sponsor's protocol ID
- 14221
- Acronym
- LovaC
- Status last verified
- Jun 2015
- First submitted
- 5 Mar 2015
- Last updated
- 16 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lovastatin on Human Platelet Proteome
- ClinicalTrials.gov ID
- NCT02389868
- Acronym / sponsor ID
- LovaC / 14221
- Conditions
- Blood Platelets Proteome
- Keywords
- Lovastatin, Proteome, Blood platelets
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Mar 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.
The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims to characterize the biological and inter-individual variation of platelet's proteome as measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of changes induced by Lovastatin on the platelet's proteome may allow the discovery of modifications relative to the effects of statins on hemostasis and the lipid profile.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lovastatin | Experimental | Drug: Lovastatin |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being an individual age 18 to 40.
- If applicable, female participants susceptible of becoming pregnant consent to use a highly efficient contraception technique AND an efficient contraception technique during the clinical trial and at least 3 months following ending the consumption of Lovastatin.
- Being able to read and understand French.
Key exclusion criteria (15 listed)
- Having a known history of dyslipidemia.
- In regard of the lipid profile at the first visit, patients that are not comprised between the 5th and the 95th percentile for LDL, HDL or Total cholesterol will be excluded.
- Having a history of hypersensitivity to Lovastatin, to one of the components of this product or to any other statin.
- Being affected by mental retardation.
- Pregnancy or suspicion of pregnancy.
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 |
|---|---|---|
| Lovastatin | Drug | Lovastatin |
Primary outcome
Change in Signal Intensity Measured for Each Protein Identified by Mass Spectrometry in Blood Platelets Lysates
Time frame: Change from Baseline Protein Level at 6 Weeks
Proteins from total platelets lysates will be analyzed by TripleTOF 5600 LC-MS/MS (AB SCIEX). The intensity measured for each identified protein will be recorded in SWATH mode. Intensities measured for each protein before (baseline) and after treatment with lovastatin (at 6 weeks) will be recorded and compared.
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 16 Jun 2015.
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 2 study testing Lovastatin in people with Blood Platelets Proteome, run by Université de Sherbrooke at 1 site in Canada.
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 16 Jun 2015. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in Signal Intensity Measured for Each Protein Identified by Mass Spectrometry in Blood Platelets Lysates (time frame: Change from Baseline Protein Level at 6 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 16 Jun 2015.