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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001630
Enrollment
500
Registered
2009-03-01
Start date
2009-01-01
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

Cerebral infarction

Interventions

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

Sponsors

Tohoku Acute Progressing Stroke Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Non-cardioembolic cerebral infarction with patient's ages > or = 20 and < 80 y.o. 2) First or recurrent stroke 3) Within 24 hours after the onset 4) Stable general condition

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactHiroaki Shimizu

Tohoku university graduate school of medicine Neuroendovascular Therapy

hshim@ivns.med.tohoku.ac.jp022-717-7230

Outcome results

None listed

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