A randomized clinical trial of an antiplatelet agent in the treatment of acute stroke: cilostazol in the prevention of acute progressing stroke (CAPS) study

UMIN ID: UMIN000001630

Registered date:01/03/2009

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebral infarction
• Date of first enrollment: 2009/01/01
• Target sample size: 500
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Control group: standard therapy Three months
Cilostazol group: cilostazol 200mg/day + standard therapy Three months

Outcome(s)

• Primary Outcome: 1) Proportion of the patients with mRS score 0 or 1 at 3 months follow-up 2) Incidence of the progressing stroke (worsening of the NIHSS score by 4 points or more)
• Secondary Outcome: 1) Incidence of cardiovascular events 2) Proportion of the patients with mRS score of 0 or 1 at 1 month follow-up 3) Proportion of patients with favorable outcome (mRS scores 0,1 or 2) at 1 and 3 months

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1) mRS before the onset > or = 2 2) NIHSS score > or = 20 3) Remarkably unstable symptom (measurement of NIHSS difficult) 4) Patients who should be treated with alteplase or other thrombolytic therapies 5) Patients who should be treated with reconstructive surgery (bypass or endovascular treatment) 6) Severe swallowing disturbance 7) Serious systemic complications (carcinoma,liver cirrhosis,renal failure, heart failure, etc.) 8) Contraindications to cilostazol 9) Patients who are considered unsuitable for inclusion in the study

Related Information

• Primary Sponsor: Tohoku Acute Progressing Stroke Study Group
• Source(s) of Monetary Support: GONRYO for the promotion of medical science