Platelet Function in Diabetic Patients With and Without Renal Impairment, and the Effects of Lipid Lowering Treatment (PLAUDIT)

Karolinska Institute

Status and phase: Completed; Phase 4

Conditions: Impaired Renal Function; Diabetes Mellitus

Treatments: Drug: Ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT01035320

EudraCT 2004-004416-22 DMK001

Details and patient eligibility

About

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.

Full description

A detailed study protocol is available.

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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/1.73m2. The abbreviated Modification of Diet in Renal Disease (MDRD) equation will be used to calculate GFR.
• Age 18-80 years

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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39 participants in 1 patient group

simvastatin + ezetimibe

Experimental group

Description:

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.

Treatment:

Drug: Ezetimibe