NCT03198715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 30, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

January 28, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

June 19, 2017

Results QC Date

January 7, 2021

Last Update Submit

January 7, 2021

Conditions

Acute Ischemic Stroke

Keywords

Fibrinolysis enhancerTAFIa inhibitorDevelopmental Phase I

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Symptomatic or Asymptomatic Intracranial Hemorrhage (ICH) Within 36 Hours From Start of Treatment With DS-1040b in Acute Ischemic Stroke Participants

    Symptomatic and asymptomatic intracranial hemorrhage (ICH) confirmed by head imaging (CT or MRI) are reported. Symptomatic ICH was defined as Intracranial hemorrhage with clinical deterioration causing an increase in the National Institutes of Health Stroke Scale (NIHSS) score of ≥ 4 points (defined by European Cooperative Acute Stroke Study). Asymptomatic ICH included the following: Hemorrhagic infarction type 1: Small petechial hemorrhage along the margins of the infarct, Hemorrhagic infarction type 2: Confluent petechial hemorrhage within the infarcted area, but without a mass effect, Parenchymal hematoma type 1: Hematoma involving ≤ 30% of the infarcted area with a slight mass effect, Parenchymal hematoma type 2: Hematoma involving \> 30% of, or outside the infarcted area, with a significant mass effect.

    From start of treatment up to 36 hours post single, intravenous dose

  • Number of Participants With Non-ICH Major Bleeding Within 96 Hours From Start of Treatment With DS-1040b In Acute Ischemic Stroke Participants

    Non-ICH was defined as a clinically evident bleeding with a 5 g/dL or greater decrease in hemoglobin.

    From start of treatment up to 96 hours post single, intravenous dose

Secondary Outcomes (8)

  • Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma

    Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose

  • Pharmacokinetic Analysis Maximum Concentration (Cmax) of DS-1040a in Plasma

    Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose

  • Pharmacokinetic Analysis Time to Maximum Concentration (Tmax) of DS-1040b in Plasma

    Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose

  • Pharmacokinetic Analysis Terminal Half-Life (T1/2) of DS-1040b in Plasma

    Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose

  • Pharmacokinetic Analysis Mean Amount of DS-1040a Excreted in Urine in Acute Ischemic Stroke Participants

    From start of treatment up to 24 hours post single, intravenous dose

  • +3 more secondary outcomes

Study Arms (5)

DS-1040b 0.6 mg

EXPERIMENTAL

Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours

Drug: DS1040b

DS-1040b 1.2 mg

EXPERIMENTAL

Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours

Drug: DS1040b

DS-1040b 2.4 mg

EXPERIMENTAL

Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours

Drug: DS1040b

DS-1040b 4.8 mg

EXPERIMENTAL

Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours

Drug: DS1040b

Placebo

PLACEBO COMPARATOR

Participants receive saline by intravenous infusion over six hours

Drug: Placebo

Interventions

DS1040bDRUG

DS-1040b in solution for intravenous infusion

Also known as: Investigational product
DS-1040b 0.6 mgDS-1040b 1.2 mgDS-1040b 2.4 mgDS-1040b 4.8 mg
PlaceboDRUG

Saline solution for intravenous infusion

Also known as: Saline solution
Placebo

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • safety or well-being of the participant or their offspring
  • safety of the study staff
  • analysis of results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hirosaki University Hospital

Hirosaki, Aomori, 036-8563, Japan

Location

Funabashi Municipal Medical Center

Funabashi, Chiba, 273-8588, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuota, 802-8555, Japan

Location

Mihara Memorial Hospital

Isesaki, Gunma, 372-0006, Japan

Location

Nakamura Memorial Hospital

Sapporo, Hokkaido, 060-8570, Japan

Location

Japan Organization of Occupational Health and Safety Kansai Rosai Hospital

Amagasaki, Hyōgo, 660-8511, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0046, Japan

Location

Hyogo College of Medicine College Hospital

Nishinomiya, Hyōgo, 663-8501, Japan

Location

University of Tsukuba Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Iwate Prefectural Central Hospital

Morioka, Iwate, 020-0066, Japan

Location

Seisho Hospital

Odawara, Kanagawa, 250-0001, Japan

Location

Yokohama Municipal Citizen's Hospital

Yokohama, Kanagawa, 240-8555, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

National Cerebral and Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Location

Saitama Medical University International Medical Center

Hidaka, Saitama, 350-1298, Japan

Location

Yamaguchi University Hospital

Ube, Yamaguchi, 755-8505, Japan

Location

Hiroshima City Hiroshima Citizens Hospital

Hiroshima, 730-8518, Japan

Location

Nagasaki University Hospital

Nagasaki, 852-8521, Japan

Location

Niigata City General Hospital

Niigata, 950-1197, Japan

Location

Wakayama Medical University Hospital

Wakayama, 641-8509, Japan

Location

Related Publications (1)

  • Sakai N, Takeuchi M, Imamura H, Shimamura N, Yoshimura S, Naito H, Kimura N, Masuo O, Hirotsune N, Morita K, Toyoda K, Yamagami H, Ishihara H, Nakatsu T, Miyoshi N, Suda M, Fujimoto S. Safety, Pharmacokinetics and Pharmacodynamics of DS-1040, in Combination with Thrombectomy, in Japanese Patients with Acute Ischemic Stroke. Clin Drug Investig. 2022 Feb;42(2):137-149. doi: 10.1007/s40261-021-01112-8. Epub 2022 Jan 21.

    PMID: 35061236DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Contact for Clinical Trial Information
Organization
Daiichi Sankyo
CTRinfo@dsi.com
908-992-6400

Study Officials

  • Global Clinical Leader

    Daiichi Sankyo

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 26, 2017

Study Start

July 30, 2017

Primary Completion

January 19, 2020

Study Completion

January 19, 2020

Last Updated

January 28, 2021

Results First Posted

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(20)