UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000001630
Receipt No. R000001960
Scientific Title A randomized clinical trial of an antiplatelet agent in the treatment of acute stroke: cilostazol in the prevention of acute progressing stroke (CAPS) study
Date of disclosure of the study information 2009/03/01
Last modified on 2009/12/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A randomized clinical trial of an antiplatelet agent in the treatment of acute stroke: cilostazol in the prevention of acute progressing stroke (CAPS) study
Acronym CAPS study
Scientific Title A randomized clinical trial of an antiplatelet agent in the treatment of acute stroke: cilostazol in the prevention of acute progressing stroke (CAPS) study
Scientific Title:Acronym CAPS study
Region
Japan

Condition
Condition Cerebral infarction
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of an antiplatelet agent cilostazol in the prevention of acute progressing stroke
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes 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)
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Control group: standard therapy
Three months
Interventions/Control_2 Cilostazol group: cilostazol 200mg/day + standard therapy
Three months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teiji Tominaga
Organization Tohoku university graduate school of medicine
Division name Department of Neurosurgery
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, SENDAI 980-8574
TEL 022-717-7230
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Shimizu
Organization Tohoku university graduate school of medicine
Division name Neuroendovascular Therapy
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, SENDAI 980-8575
TEL 022-717-7230
Homepage URL
Email hshim@ivns.med.tohoku.ac.jp

Sponsor
Institute Tohoku Acute Progressing Stroke Study Group
Institute
Department

Funding Source
Organization GONRYO for the promotion of medical science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2008 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2010 Year 09 Month 01 Day
Date of closure to data entry
2010 Year 10 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2011 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 01 Month 10 Day
Last modified on
2009 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001960

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.