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

January 7, 2021 updated by: Daiichi Sankyo Co., Ltd.

A Phase I, Single Blind, Placebo-controlled, Randomized Study to Assess the Safety of DS-1040b in Subjects With Thrombectomy Treated Acute Ischemic Stroke.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Investigational product
Placebo Comparator: Placebo
Participants receive saline by intravenous infusion over six hours
Drug: Placebo
Saline solution for intravenous infusion
Other Names:
  • Saline solution

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: From start of treatment up to 36 hours post single, intravenous dose
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
Time Frame: From start of treatment up to 96 hours post single, intravenous dose
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Analysis Area Under The Plasma Concentration Time Curve (AUC) of DS-1040a in Plasma
Time Frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
The pharmacokinetic (PK) parameter of area under the plasma concentration-time curve up to the last quantifiable time was calculated using linear up logarithmic down rule.
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
Time Frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
The PK parameter of maximum concentration (Cmax) was observed values.
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
Time Frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
The PK parameter of time to maximum concentration (Tmax) was observed values. When there are more than one time point, the time point when the concentration reached the first Cmax will be used as Tmax.
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
Time Frame: Predose, 0.5 hours (h), 3 h, 6 h, 18 h, 24 h, 48 h, and 96 h post single, intravenous dose
The PK parameter of terminal half-life (T1/2) was calculated from the following formula in participants whose Kel could be calculated. T1/2=ln2 / Kel
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
Time Frame: From start of treatment up to 24 hours post single, intravenous dose

The pharmacokinetic parameter of amount of drug excreted in urine was calculated from the following formula:

urine concentration (ng/mL) /10^6× (urine weight / urinary specific gravity)
From start of treatment up to 24 hours post single, intravenous dose
Pharmacodynamic Analysis Thrombin Activatable Fibrinolysis Inhibitor (TAFI) Antigen Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Time Frame: Baseline, 6 hours and 24 hours post single, intravenous dose
The mean thrombin activatable fibrinolysis (TAFI) antigen levels and change from baseline in TAFI levels are reported. Change from baseline is based on the number of participants with baseline and at least one post-baseline laboratory test.
Baseline, 6 hours and 24 hours post single, intravenous dose
Pharmacodynamic Analysis D-dimer Levels in Plasma and Change From Baseline in Acute Ischemic Stroke Participants
Time Frame: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose
Mean D-dimer levels and change from baseline in D-dimer levels are reported.Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose
Pharmacodynamic Analysis Activated Form of Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) Activity and Change From Baseline in Acute Ischemic Stroke Participants
Time Frame: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose
Mean activated form of thrombin-activatable fibrinolysis inhibitor (TAFIa) and change from baseline in TAFIa are reported. Change from baseline is based on the number of subjects with baseline and at least one post-baseline laboratory test.
Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS1040-A-J110
  • 173612 (Registry Identifier: JAPIC CTI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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