UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001630 |
|---|---|
| Receipt number | 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 17:34:04 |
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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
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
hshim@ivns.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Acute Progressing Stroke Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001960
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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