AtherosclerosisEarly Phase 1NCT02548936
Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLE
A Early Phase 1 study testing Ezetimibe+Simvastatin Drug Combination in people with Atherosclerosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a randomized single-blind trial. This study aimed to determine if intensive lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the progression of atherosclerosis effectively and safely among SLE patients with carotid artery intima thickening. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Ezetimibe+Simvastatin Drug Combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2016
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years and clinical diagnosis of SLE
- abnormal CIMT (≥0.9 mm at any site) by B-mode ultrasound
- LDL-C≥100mg/dl
- a signed written informed consent was able to be obtained.
Who cannot join
- atherosclerotic cardiovascular disease
- diabetes
- history of intolerance or allergy to the statins or ezetimibe
- had ever received statins or ezetimibe within 12 months of study entry
- LDL-C≥190mg/dl
- active infection
Show all 9Show fewer
- ALT was higher than 2 times of the upper normal limit or CK was higher than 1.5 times of the upper normal limit.
- pregnant or lactating women
- patients with severe SLE.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind Trial
This is a randomized single-blind trial. This study aimed to determine if intensive lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the progression of atherosclerosis effectively and safely among SLE patients with carotid artery intima thickening. The study results were expected to be helpful for SLE patients in preventing atherosclerosis.
Read the detailed description
Patient Registries: A convenient consecutive sampling was used to recruit participants from outpatients in department of rheumatism of PUMCH. Prior to their enrollment in the study, all patients gave written, informed consent. To minimize subject non-response or rejection, the investigators inform patients the benefits and risks, and feedback them all physical examination results for free in the recruit period.
Randomization: A randomization will be used to allocate patients into Lipid-lowering treatment group and control group.
Blind: A trained ultrasonographer who assessed carotid intima media thickness (CIMT) (at baseline and 12 months) will be blinded to all clinical and treatment information.
Statistical analysis: The characteristics of the study sample were summarized using descriptive statistics with dichotomous or ordinal data presented as percentages and continuous data as means, standard deviations, and medians, interquartile range. Differences of progression rate of atherosclerosis between intervention group and control group were assessed with either the t test or the non-parametric Wilcoxon test. A multivariable linear regression model will be used to evaluate the relationship between the progression of CIMT and intervention after controlling for confounding factors. Statistical significance was defined as a 2-tailed P value less than 0.05. All calculations were performed using SAS version 9.3.
Quality Control and Data Management: Two doctors (not the main investigator) who come from department of cardiology with the experiences of clinical trial and a data manager will be serving as Data and Safety Monitor. A monthly meeting will be set up for investigators and monitors. The monitors need to review the study protocol and set Data Safety Management plan before recruitment. Then, they need to review rates of recruitment, adherence, follow-up conditions and assess the efficacy and harm during the study. If Monitors find that the simvastatin-ezetimibe combination therapy is causing severe adverse event, then a detailed record is needed. Monitors need to inform the main investigator within 3 hours and to inform state China Food and Drug Administration within 24 hours. Interim monitoring will focus on data quality, percentage of AE or SAE, and evidence of benefit.
- Conditions
- Atherosclerosis
- Being tested
- Ezetimibe+Simvastatin Drug Combination
- Keywords
- Cholesterol, LDL, Carotid Intima-Media Thickness, Atherosclerosis, Ezetimibe, Simvastatin Drug Combination, Lupus Erythematosus, Systemic
- Medical subject headings
- Atherosclerosis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe+Simvastatin Drug CombinationDrug
Also called ezetimibe/simvastatin
The patients in Ezetimibe+Simvastatin Drug Combination group received simvastatin (10mg/day) + ezetimibe (20 mg/day) by oral administration for 12 month.
| Study group | Role | What they receive |
|---|---|---|
| Lipid-lowering treatment | Experimental | The Lipid-lowering treatment is Ezetimibe+Simvastatin Drug Combination by oral administration. The patients in intervention group received simvastatin (10mg/day) + ezetimibe (20 mg/day) combined therapy for 12 month. Receives: Drug: Ezetimibe+Simvastatin Drug Combination |
| No lipid-lowering treatment | No intervention | Without any Lipid-lowering treatment for 12 month. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of carotid intima media thickness over 12 months
CIMT(Unit: millimeter) is defined as the distance between the lumen-intima interface and the media-adventitia interface, which corresponded to the inner and outer echogenic lines seen on the B-mode ultrasound image.
Measured: baseline, 12 months
Secondary outcomes (8)
The rate of abnormal elevated alanine aminotransferase (ALT)
ALT >40U/L
Measured: 1 month
The rate of abnormal elevated alanine aminotransferase
ALT >40U/L
Measured: 3 months
The rate of abnormal elevated alanine aminotransferase
ALT >40U/L
Measured: 6 months
The rate of abnormal elevated alanine aminotransferase
ALT >40U/L
Measured: 12 months
The rate of abnormal elevated creatine kinase (CK)
CK >60U/L
Measured: 1 month
The rate of abnormal elevated creatine kinase
CK >60U/L
Measured: 3 month
The rate of abnormal elevated creatine kinase
CK >60U/L
Measured: 6 month
The rate of abnormal elevated creatine kinase
CK >60U/L
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuyang Zhang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548936
- Sponsor's protocol ID
- pumch-sleas
- Status last verified
- Aug 2015
- First submitted
- 31 Aug 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind Trial
- ClinicalTrials.gov ID
- NCT02548936
- Acronym / sponsor ID
- pumch-sleas
- Conditions
- Atherosclerosis
- Keywords
- Cholesterol, LDL, Carotid Intima-Media Thickness, Atherosclerosis, Ezetimibe, Simvastatin Drug Combination, Lupus Erythematosus, Systemic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Sep 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.
This is a randomized single-blind trial. This study aimed to determine if intensive lipid-lowering therapy (simvastatin-ezetimibe combination therapy) could reduce the progression of atherosclerosis effectively and safely among SLE patients with carotid artery intima thickening. The study results were expected to be helpful for SLE patients in preventing atherosclerosis.
Detailed description
Patient Registries: A convenient consecutive sampling was used to recruit participants from outpatients in department of rheumatism of PUMCH. Prior to their enrollment in the study, all patients gave written, informed consent. To minimize subject non-response or rejection, the investigators inform patients the benefits and risks, and feedback them all physical examination results for free in the recruit period.
Randomization: A randomization will be used to allocate patients into Lipid-lowering treatment group and control group.
Blind: A trained ultrasonographer who assessed carotid intima media thickness (CIMT) (at baseline and 12 months) will be blinded to all clinical and treatment information.
Statistical analysis: The characteristics of the study sample were summarized using descriptive statistics with dichotomous or ordinal data presented as percentages and continuous data as means, standard deviations, and medians, interquartile range. Differences of progression rate of atherosclerosis between intervention group and control group were assessed with either the t test or the non-parametric Wilcoxon test. A multivariable linear regression model will be used to evaluate the relationship between the progression of CIMT and intervention after controlling for confounding factors. Statistical significance was defined as a 2-tailed P value less than 0.05. All calculations were performed using SAS version 9.3.
Quality Control and Data Management: Two doctors (not the main investigator) who come from department of cardiology with the experiences of clinical trial and a data manager will be serving as Data and Safety Monitor. A monthly meeting will be set up for investigators and monitors. The monitors need to review the study protocol and set Data Safety Management plan before recruitment. Then, they need to review rates of recruitment, adherence, follow-up conditions and assess the efficacy and harm during the study. If Monitors find that the simvastatin-ezetimibe combination therapy is causing severe adverse event, then a detailed record is needed. Monitors need to inform the main investigator within 3 hours and to inform state China Food and Drug Administration within 24 hours. Interim monitoring will focus on data quality, percentage of AE or SAE, and evidence of benefit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipid-lowering treatment | Experimental | Drug: Ezetimibe+Simvastatin Drug CombinationThe Lipid-lowering treatment is Ezetimibe+Simvastatin Drug Combination by oral administration. The patients in intervention group received simvastatin (10mg/day) + ezetimibe (20 mg/day) combined therapy for 12 month. |
| No lipid-lowering treatment | No intervention | –Without any Lipid-lowering treatment for 12 month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18 years and clinical diagnosis of SLE
- abnormal CIMT (≥0.9 mm at any site) by B-mode ultrasound
- LDL-C≥100mg/dl
- a signed written informed consent was able to be obtained.
Key exclusion criteria (9 listed)
- atherosclerotic cardiovascular disease
- diabetes
- history of intolerance or allergy to the statins or ezetimibe
- had ever received statins or ezetimibe within 12 months of study entry
- LDL-C≥190mg/dl
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 |
|---|---|---|
| Ezetimibe+Simvastatin Drug CombinationAlso: ezetimibe/simvastatinThe patients in Ezetimibe+Simvastatin Drug Combination group received simvastatin (10mg/day) + ezetimibe (20 mg/day) by oral administration for 12 month. | Drug | Lipid-lowering treatment |
Primary outcome
The change of carotid intima media thickness over 12 months
Time frame: baseline, 12 months
CIMT(Unit: millimeter) is defined as the distance between the lumen-intima interface and the media-adventitia interface, which corresponded to the inner and outer echogenic lines seen on the B-mode ultrasound image.
8 secondary outcomes
The rate of abnormal elevated alanine aminotransferase (ALT)
Time frame: 1 month
The rate of abnormal elevated alanine aminotransferase
Time frame: 3 months
The rate of abnormal elevated alanine aminotransferase
Time frame: 6 months
The rate of abnormal elevated alanine aminotransferase
Time frame: 12 months
The rate of abnormal elevated creatine kinase (CK)
Time frame: 1 month
The rate of abnormal elevated creatine kinase
Time frame: 3 month
The rate of abnormal elevated creatine kinase
Time frame: 6 month
The rate of abnormal elevated creatine kinase
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
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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.
Shuyang Zhang, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ezetimibe+Simvastatin Drug Combination in people with Atherosclerosis, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Sep 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 change of carotid intima media thickness over 12 months (time frame: baseline, 12 months). 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 14 Sep 2015.