Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2.
研究概览
简要总结
The purpose of this study is compare the effects of simvastatin+ezetimibe with those of simvastatin alone on platelet activity, platelet-leukocyte interactions and inflammatory variables in diabetic patients with or without impaired renal function.
详细描述
A detailed study protocol is available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 1 or type 2
- •With or without established microalbuminuria (albumin-to-creatinine ratio (ACR)2,5-25 mg/mmol for men, and 3,5-25 mg/mmol for women, according to ISH and ESC recommended criteria)
- •Glomerular filtration rate (GFR) between 15-60 ml/min/1.73m2 (measured the last 6 months) or GFR >75ml/min/1.73m
- •The abbreviated Modification of Diet in Renal Disease (MDRD) equation will be used to calculate GFR.
- •Age 18-80 years
排除标准
- •Definite history of myocardial infarction, coronary revascularisation procedure or stroke. (i.e, a strong clinical indication for statin treatment)
- •Functioning renal transplant, or living donor-related transplant planned.
- •Patients on dialysis.
- •Poor metabolic control, i.e HbA1c > 9%
- •Definite history of chronic liver disease, or abnormal liver function (i.e ALT >1,5 x ULN or, if ALT not available, AST > 1,5 x ULN).
- •Evidence of active inflammatory muscle disease (e.g dermatomyositis, polymyositis), or CK>3 x ULN;
- •Definite previous adverse reaction to a statin or to ezetimibe
- •Definite previous adverse reaction to acetylsalicylic acid.
- •Definite previous adverse reaction to an ACE-inhibitor.
- •Need for concomitant treatment with a strong inhibitor of CYP3A4, such as itrokonazole, ketokonazole, erythromycin, clarithromycin, HIV-protease inhibitors or nefazodone (i.e. agents that may markedly elevate simvastatin levels).
研究组 & 干预措施
simvastatin + ezetimibe
Cross-over study with placebo only run-in period. All patients participate in this arm with simvastatin + ezetimibe either as first treatment period (8-10 weeks)or second treatment period (8-10 weeks). The primary comparison is ezetimibe vs. placebo on top of simvastatin. A secondary comparison will be simvastatin vs. placebo run-in.
干预措施: Ezetimibe (Drug)
结局指标
主要结局
Compare the effects of simvastatin + ezetimibe with those of simvastatin alone, on thrombogenic mechanisms, in patients with diabetes mellitus type 2.
时间窗: 6 weeks, 14-18 weeks, 22-24 weeks
次要结局
- Compare effects of simvastatin alone with those of placebo on thrombogenic mechanisms. Compare the effects of simvast. + ezetim. with those of simvast. alone on inflammatory variables. Assess how the treatment effect relate to renal function.(6 weeks, 14-18 weeks, 22-24 weeks)
研究者
Paul Hjemdahl
Professor
Karolinska Institutet