UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022911 |
|---|---|
| Receipt number | R000026397 |
| Scientific Title | Pioneering study on activated platelets in thrombus and embolus formation among stroke patients joint study between Yokohama and Morioka |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2016/07/04 16:02:26 |
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Basic information
Public title
Pioneering study on activated platelets in thrombus and embolus formation among stroke patients joint study between Yokohama and Morioka
Acronym
PATHFINDER
Scientific Title
Pioneering study on activated platelets in thrombus and embolus formation among stroke patients joint study between Yokohama and Morioka
Scientific Title:Acronym
PATHFINDER
Region
| Japan |
Condition
Condition
cerebral embolism due to non-valvular atrial fibrillation (NVAF)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect on platelet aggregation of Dabigatran (Prazaxa R) among patients with embolic stroke due to NVAF
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
activity of anti PAR-1 antibody and platelet aggregation before, 4 weeks, and 8 weeks after administration of Dabigatran (Prazaxa R)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 50 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age more than 50 years old
2) patients with NVAF who are not taking anti platelets and/or oral anti coagulants
3) Davigatran-naive patients with NVAF
Key exclusion criteria
1) current internal bleeding, history of increased bleeding risk, or planned procedure with risk of uncontrolled bleeding
2) patients with renal disfunction (CrCl <30mL/min)
3) patients with clinical risk of hemorrhage (including hemorrhagic stroke within 6 months)
4) patients with indwelling spinal or epidural catheterization or patients at least 1 hur after the procedure
5) patients taking itraconazole
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Terayama |
Organization
Iwate Medical University
Division name
Division of Neurology and Gerontology, Department of Internal Medicine
Zip code
Address
19-1 Uchimaru, Morioka , Iwate 020-8505 Japan
TEL
019-651-5111
teray@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Terayama |
Organization
Iwate Medical University
Division name
Division of Neurology and Gerontology, Department of Internal Medicine
Zip code
Address
19-1 Uchimaru, Morioka, Iwate 020-8505 Japan
TEL
019-651-5111
Homepage URL
teray@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2016 | Year | 06 | Month | 27 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurement of platelets aggregation and anti PAR-1 antibody among normal subjects and patients with NVAF is on going.
Management information
Registered date
| 2016 | Year | 06 | Month | 27 | Day |
Last modified on
| 2016 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026397
