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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
Beijing
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Beijing、Beijing、中国、100730
- Peking Union Medical College Hospital
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
他の名前:
|
介入なし:No lipid-lowering treatment
Without any Lipid-lowering treatment for 12 month.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The change of carotid intima media thickness over 12 months
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
The rate of abnormal elevated alanine aminotransferase (ALT)
時間枠:1 month
|
ALT >40U/L
|
1 month
|
The rate of abnormal elevated alanine aminotransferase
時間枠:3 months
|
ALT >40U/L
|
3 months
|
The rate of abnormal elevated alanine aminotransferase
時間枠:6 months
|
ALT >40U/L
|
6 months
|
The rate of abnormal elevated alanine aminotransferase
時間枠:12 months
|
ALT >40U/L
|
12 months
|
The rate of abnormal elevated creatine kinase (CK)
時間枠:1 month
|
CK >60U/L
|
1 month
|
The rate of abnormal elevated creatine kinase
時間枠:3 month
|
CK >60U/L
|
3 month
|
The rate of abnormal elevated creatine kinase
時間枠:6 month
|
CK >60U/L
|
6 month
|
The rate of abnormal elevated creatine kinase
時間枠:12 month
|
CK >60U/L
|
12 month
|
協力者と研究者
捜査官
- 主任研究者:Shuyang Zhang, MD、Peking Union Medical College Hospital
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- pumch-sleas
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