Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patients

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2014
INTERVENTION: Antiplatelet monotherapy (excluding cilostazol) and statin monotherapy Aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg) will be orally administrated once daily. Statin (atorvastatin 10mg, pitavastatin 2mg or rosuvastatin 2.5mg) will be orally administered once daily. The treatment will begin within 7 days from the onset of noncardioembolic stroke. Experimental: DAPT and DADT Dual antiplatelet therapy including cilostazol and dual antidyslipidemia therapy including eicosapentaenoic acid and statin Cilostazol (100mg twice daily) will be orally administered in combination with aspirin (81mg or 100mg) or clopidogrel (50mg or 75mg). Eicosapentaenoic acid (900mg twice daily) will be orally administered in combination with statin (atorvastatin 10mg, pitavastatin 2mg or rosuvastatin 2.5mg once daily). The treatment will begin within 7 days from the onset of noncardioembolic stroke. CONDITION: Non‐cardioembolic cerebral infarction PRIMARY OUTCOME: Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours SECONDARY OUTCOME: Any stroke [ischemic stroke (IS), intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH)]; IS or transient ischemic attack (TIA); ICH or SAH; Death from any cause; Stroke (IS, ICH, SAH), myocardial infarction (MI), or vascular events; All vascular events: stroke, MI, and other vascular events; Adverse events and adverse drug reactions; Severe or life‐threatening hemorrhage (GUSTO Criteria) INCLUSION CRITERIA: Patients with a diagnosis of noncaridioembolic IS that developed within 7 days before the start of the protocol treatment Patients with a responsible lesion identified by MRI Patients with dyslipidemia (total chlolesterol > 6.0nmol/L) or under the treatment of dyslipidemia Patients taking clopidogrel or aspirin as antiplatelet therapy when providing informed consent Patients aged 40 to 85 years old when providing informed consent Patients considered to be able to visit the study site Patients who provided written informed consent
Epistemonikos ID: 865894b96b1d15cb52130d4426ccaafaadc443ef
First added on: Aug 22, 2024