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Safety of DS-1040b in Acute Ischemic Stroke Patients Treated With Thrombectomy

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ClinicalTrials.gov Identifier: NCT03198715
Recruitment Status : Recruiting
First Posted : June 26, 2017
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
The aim of this study is to find out if DS-1040b is safe and tolerable in acute ischemic stroke patients with thrombectomy. Four groups will receive different doses of DS-1040b by intravenous infusion for 6 hours. Groups with the lowest dose will start. When it is determined that each dose is safe and tolerable, the next higher dose will be given to the next group.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: DS1040b Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase I, Single Blind, Placebo-controlled, Randomized Study to Assess the Safety of DS-1040b in Subjects With Thrombectomy Treated Acute Ischemic Stroke.
Actual Study Start Date : July 30, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: DS-1040b 0.6 mg
Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Name: Investigational product

Experimental: DS-1040b 1.2 mg
Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Name: Investigational product

Experimental: DS-1040b 2.4 mg
Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Name: Investigational product

Experimental: DS-1040b 4.8 mg
Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours
Drug: DS1040b
DS-1040b in solution for intravenous infusion
Other Name: Investigational product

Placebo Comparator: Placebo
Participants receive saline by intravenous infusion over six hours
Drug: Placebo
Saline solution for intravenous infusion
Other Name: Saline solution




Primary Outcome Measures :
  1. Number of participants with intracranial hemorrhage (ICH), with or without symptoms, within 36 hours from start of treatment [ Time Frame: within 36 hours from start of treatment ]
  2. Number of participants with non-ICH major bleeding within 96 hours from start of treatment [ Time Frame: within 96 hours from start of treatment ]

Secondary Outcome Measures :
  1. Area under the plasma concentration time curve (AUC) of DS-1040a in plasma [ Time Frame: within 96 hours from start of treatment ]
  2. Maximum concentration (Cmax) of DS-1040a in plasma [ Time Frame: within 96 hours from start of treatment ]
  3. Time to maximum concentration (Tmax) of DS-1040a in plasma [ Time Frame: within 96 hours from start of treatment ]
  4. Terminal half-life (T1/2) of DS-1040a in plasma [ Time Frame: within 96 hours from start of treatment ]
  5. Amount of drug excreted in urine of DS-1040a [ Time Frame: within 24 hours from start of treatment ]
  6. Thrombin activatable fibrinolysis inhibitor (TAFI) antigen in plasma [ Time Frame: within 48 hours from start of treatment ]
  7. D-dimer in plasma [ Time Frame: within 48 hours from start of treatment ]
  8. Total TAFIa inhibitor in plasma [ Time Frame: within 48 hours from start of treatment ]


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Ages Eligible for Study:   20 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is an acute ischemic stroke patients with evidence of intracranial vascular occlusion
  • Is enrolled in principle within 8 hours of symptom onset
  • Has treatment plan that includes stent retriever
  • Has protocol-defined scores on several scales

Exclusion Criteria:

  • Has treatment plan that includes fibrinolysis or fibinolysis
  • Has identified intracranial hemorrhage or subarachnoid hemorrhage
  • Has active bleeding like gastrointestinal hemorrhage
  • Has cerebral bleeding risk; intracranial tumor, brain aneurysm, cerebral arteriovenous malformation, or history of intracranial bleeding
  • Has severe hepatic or renal impairment
  • Has been a participant in other clinical trial within 30 days prior to treatment
  • Is pregnant, lactating, or planning on becoming pregnant during treatment period
  • Has any condition or history that might, per protocol or in the opinion of the investigator, compromise:

    1. safety or well-being of the participant or their offspring
    2. safety of the study staff
    3. analysis of results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198715


Contacts
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Contact: Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp

Locations
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Japan
Hirosaki University Hospital Recruiting
Hirosaki, Aomori, Japan, 036-8563
Funabashi Municipal Medical Center Recruiting
Funabashi, Chiba, Japan, 273-8588
Kokura Memorial Hospital Recruiting
Kitakyushu, Fukuota, Japan, 802-8555
Mihara Memorial Hospital Recruiting
Isesaki, Gunma, Japan, 372-0006
Nakamura Memorial Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8570
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital Recruiting
Amagasaki, Hyogo, Japan, 660-8511
Kobe City Medical Center General Hospital Recruiting
Kobe, Hyogo, Japan, 650-0046
Hyogo College of Medicine College Hospital Recruiting
Nishinomiya, Hyogo, Japan, 663-8501
University of Tsukuba Hospital Recruiting
Tsukuba, Ibaraki, Japan, 305-8576
Iwate Prefectural Central Hospital Recruiting
Morioka, Iwate, Japan, 020-0066
Seisho Hospital Recruiting
Odawara, Kanagawa, Japan, 250-0001
Yokohama Municipal Citizen's Hospital Recruiting
Yokohama, Kanagawa, Japan, 240-8555
Mie University Hospital Recruiting
Tsu, Mie, Japan, 514-8507
National Cerebral and Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Saitama Medical University International Medical Center Recruiting
Hidaka, Saitama, Japan, 350-1298
Yamaguchi University Hospital Recruiting
Ube, Yamaguchi, Japan, 755-8505
Hiroshima City Hiroshima Citizens Hospital Recruiting
Hiroshima, Japan, 730-8518
Nagasaki University Hospital Recruiting
Nagasaki, Japan, 852-8521
Niigata City General Hospital Recruiting
Niigata, Japan, 950-1197
Wakayama Medical University Hospital Recruiting
Wakayama, Japan, 641-8509
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

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Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT03198715     History of Changes
Other Study ID Numbers: DS1040-A-J110
173612 ( Registry Identifier: JAPIC CTI )
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Fibrinolysis enhancer
TAFIa inhibitor
Developmental Phase I
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Pharmaceutical Solutions