Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial.

UMIN ID: C000000296

Registered date:16/12/2005

Basic Information

• Health condition(s) or Problem(s) studied: Ischemic stroke
• Date of first enrollment: 2006/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Patients will be randomly selected to receive combined therapy with ozagrel Na and cilostazol for 14 days. Cilostazol will be administered orally at a daily dose of 200mg.
Patients will also be randomly selected to receive treatment with ozagrel Na alone for 14 days.

Outcome(s)

• Primary Outcome: The frequency of patients with 'minimal or no neurological disability (defined as modified Rankin scale 0-2)' at 1 month into the treatment.
• Secondary Outcome: (1)The frequency of neurological deterioration within 14 days into the treatment. (2)NIHSS at 1 month into the treatment (3)BI at 1 month into the treatment (4)Vascular or other adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1)Occlusive lesion of the internal carotid artery or the middle cerebral artery (2)Hemorrhagic disorders (3)Congestive heart failure (4)Embolic stroke (5)Severe liver and renal dysfunction (6)Malignant disorders (7)Taking cilostazol, ticlipidine , aspirin or warfarin (8)The patient participating in other clinical trials

Related Information

• Primary Sponsor: Kohnan Hospital Department of Neuroendovascular Therapy
• Secondary Sponsor: None
• Source(s) of Monetary Support: None