UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014405 |
|---|---|
| Receipt number | R000016748 |
| Scientific Title | Argatroban, aspirin and clopidgrel combination therapy for non-cardioembolic acute ischemic stroke -a prospective, randomized, argatroban and aspirin-controlled study- |
| Date of disclosure of the study information | 2014/06/27 |
| Last modified on | 2016/02/01 19:09:18 |
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Basic information
Public title
Argatroban, aspirin and clopidgrel combination therapy for non-cardioembolic acute ischemic stroke -a prospective, randomized, argatroban and aspirin-controlled study-
Acronym
Dual antiplatelet therapy for non-cardioembolic acute ischemic stroke
Scientific Title
Argatroban, aspirin and clopidgrel combination therapy for non-cardioembolic acute ischemic stroke -a prospective, randomized, argatroban and aspirin-controlled study-
Scientific Title:Acronym
Dual antiplatelet therapy for non-cardioembolic acute ischemic stroke
Region
| Japan |
Condition
Condition
Acute non-cardioembolic stroke
Classification by specialty
| Neurology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of combination therapy (argatoroban, aspirin and clopidgrel)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. NIHSS score at 7 days after admission and at day of discharge
2. modified Rankin scale score at 3 months after stroke
Key secondary outcomes
1. outcome at hospital discharge
2. TIA, stroke recurrence, intracranial hemorrhage, cardiovascular event within 3 months after stroke
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Dual antiplatelet group:
argatoroban, aspirin 100mg (day1 200mg), cropidogrel 75mg(day1 300mg) for 7 days, after day 7 mono antiplatelet agent
Interventions/Control_2
Mono antiplatelet group:
argatroban, aspirin 100mg (day1 200mg) for 7 days, after day 7 mono antiplatelet agent
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. non-cardioembolic stroke within 48 hours of onset
2. small vessel disease (lacunar or BAD (branch atheromatous disease))
3. NIHSS score below 20 points on admission
4. mRS score 0-2 before onset
5. patients written informed consent
Key exclusion criteria
1. cardioembolic stroke
2. antithrombotic therapy (cilostazol, ticlopidine, aspirin 100mg over, clopidogrel 75mg over, anticoagulants) before onset
3. congestive heart failure
4. medical history of allergies of argatroban, aspirin, clopidogrel
5. blood pressure cannot be controlled below 180/105mmHg
6. high hemorrhagic risk
7. severe stenosis of major cerebral and cervical artery
8. patients who are not appropriate to participate in this trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoji Nishi |
Organization
Okazaki City Hospital
Division name
Department of Neurology
Zip code
Address
1-3 Gosyoai Kouryuji-cho Okazaki, Aichi
TEL
0564-21-8111
nishi-r@gc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryoji Nishi |
Organization
Okazaki City Hospital
Division name
Department of Neurology
Zip code
Address
1-3 Gosyoai Kouryuji-cho Okazaki, Aichi
TEL
0564-21-8111
Homepage URL
nishi-r@gc4.so-net.ne.jp
Sponsor or person
Institute
Department of Neurology Okazaki City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
岡崎市民病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016748
