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

Randamized clinical trial of reduction in the recurrence of acute noncardioembolic stroke by Cilostazol and Eicosapentaneic acid for hypercholesterolemic patients - Cilostazol and EPA stroke prevention study (CESP study)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013864
Enrollment
500
Registered
2014-05-01
Start date
2014-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-cardioembolic cerebral infarction

Interventions

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, pitava

Sponsors

Department of Neurology, Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

Exclusion criteria

Exclusion criteria: Patients with a history of acute myocardial infarction within six months Patients with congestive heart failure or uncontrolled angina pectoris Patients with a history of caridiovascular angioplasty within six months Patients with severe liver or renal dysfunction Patients with a malignant tumor requiring treatment Patients with uncontrolled diabetes mellitus Patients with secondary dyslipidemia (due to corticosteroid etc) Patients with hemorrhagic diseases (eg. Hemophilia, hemorrhagic intestinal diseases, hemorrhage from gastrointesitinal tract and urinary tract, hemoptysis) Patients with hypersensitivity to aspirin, clopidogrel or cilostazol Patients scheduled to undergo any surgery during the study period Patients considered by the investigator/subinvestigator to be unsuitable for participating in this study

Design outcomes

Primary

MeasureTime frame
Recurrence of symptomatic ischemic stroke, with the symptoms lasting for at least 24 hours

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactHiroo Terashi

Tokyo Medical University Department of Neurology

terashi@tokyo-med.ac.jp+81-3-3342-6111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026