UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pioneering study on activated platelets in thrombus and embolus formation among stroke patients joint study between Yokohama and Morioka
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasuo Terayama
Organization	Iwate Medical University
Division name	Division of Neurology and Gerontology, Department of Internal Medicine
Address	19-1 Uchimaru, Morioka , Iwate 020-8505 Japan
TEL	019-651-5111
Email	teray@iwate-med.ac.jp

Public contact
Name of contact person	Yasuo Terayama
Organization	Iwate Medical University
Division name	Division of Neurology and Gerontology, Department of Internal Medicine
Address	19-1 Uchimaru, Morioka, Iwate 020-8505 Japan
TEL	019-651-5111
Homepage URL
Email	teray@iwate-med.ac.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026397