- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02548936
Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLE
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Prima fase 1
Contatti e Sedi
Luoghi di studio
-
-
Beijing
-
Beijing, Beijing, Cina, 100730
- Peking Union Medical College Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Lipid-lowering treatment
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.
|
The patients in Ezetimibe+Simvastatin Drug Combination group received simvastatin (10mg/day) + ezetimibe (20 mg/day) by oral administration for 12 month.
Altri nomi:
|
Nessun intervento: No lipid-lowering treatment
Without any Lipid-lowering treatment for 12 month.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The change of carotid intima media thickness over 12 months
Lasso di tempo: 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.
|
baseline, 12 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The rate of abnormal elevated alanine aminotransferase (ALT)
Lasso di tempo: 1 month
|
ALT >40U/L
|
1 month
|
The rate of abnormal elevated alanine aminotransferase
Lasso di tempo: 3 months
|
ALT >40U/L
|
3 months
|
The rate of abnormal elevated alanine aminotransferase
Lasso di tempo: 6 months
|
ALT >40U/L
|
6 months
|
The rate of abnormal elevated alanine aminotransferase
Lasso di tempo: 12 months
|
ALT >40U/L
|
12 months
|
The rate of abnormal elevated creatine kinase (CK)
Lasso di tempo: 1 month
|
CK >60U/L
|
1 month
|
The rate of abnormal elevated creatine kinase
Lasso di tempo: 3 month
|
CK >60U/L
|
3 month
|
The rate of abnormal elevated creatine kinase
Lasso di tempo: 6 month
|
CK >60U/L
|
6 month
|
The rate of abnormal elevated creatine kinase
Lasso di tempo: 12 month
|
CK >60U/L
|
12 month
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Shuyang Zhang, MD, Peking Union Medical College Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Arteriosclerosi
- Malattie arteriose occlusive
- Aterosclerosi
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Antimetaboliti
- Agenti anticolesteremici
- Agenti ipolipidemizzanti
- Agenti regolatori dei lipidi
- Inibitori dell'idrossimetilglutaril-CoA reduttasi
- Simvastatina
- Ezetimibe
- Ezetimibe, combinazione di farmaci Simvastatina
Altri numeri di identificazione dello studio
- pumch-sleas
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .