transitoric ischemic attack or cerebral ischemia
Conditions
Interventions
Trade Name: Plavix
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Clopidogrel
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Trade Name: Locol
P
Sponsors
Dresden University of Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age 40 – 80 years - TIA or first ischemic stroke - NIHSS 5 mmol/l, Serum-LDL-C > 3 mmol/l - Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pre- treatment with ASS or other anticoagulant medication within the last 6 weeks - Pre-treatment with lipid-lowering agents within the last 6 weeks - Thrombolysis in acute stroke - Previous stroke - Malignant systemic disease - Dementia - Bathel-Index > 1 - Known liver damage or persistent ellevation of liver enzymes - Known or current abuse of drugs, medications or alcohol - Subjects unlikely to comply with the requirements of the protocol - Pregnancy or lactation - Women with child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they meet the following definition of post-menopausal: 12 month of natural (spontaneous) amenorrhea or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or are using a highly effective method of birth control (defined as those which result in a low failure rate, i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomized partner - Participation in another clinical trial within the last 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to demonstrate that fluvastatin 80 mg extended release (ER) has no effect on the inhibition of platelet aggregation by clopidogrel, where as atorvastatin reduces the anticoagulant effect of clopidogrel. The primary parameter will be ADP stimulated platelet aggregation.;Secondary Objective: - safety of the medication used in the trial - lipid lowering potency of fluvastatin and simvastatin - active metabolite of clopidogrel;Primary end point(s): Platelet aggregation after the treatment with the combination of clopidogrel / simvastatin and the combination of clopidogrel / fluvastatin. | — |
Countries
Germany
Outcome results
None listed