Acute Ischemic StrokeNCT03198715

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

A study testing DS1040b in people with Acute Ischemic Stroke, run by Daiichi Sankyo Co., Ltd. at 20 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 20 to 89 years
Conditions the study is for: Acute Ischemic Stroke
What is being tested?: DS1040b
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 20 sitesJapan
Study dates: 30 Jul 2017to 19 Jan 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

Japan20 sites

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

Other trials in Japan

About this study

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.

Conditions: Acute Ischemic Stroke
Being tested: DS1040b, Placebo
Keywords: Fibrinolysis enhancer, TAFIa inhibitor, Developmental Phase I
Medical subject headings: Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DS1040bDrug
Also called Investigational product
DS-1040b in solution for intravenous infusion
PlaceboDrug
Also called Saline solution
Saline solution for intravenous infusion

Study groups in NCT03198715
Study group	Role	What they receive
DS-1040b 0.6 mg	Experimental	Participants receive DS-1040b 0.6 mg by intravenous infusion over six hours Receives: Drug: DS1040b
DS-1040b 1.2 mg	Experimental	Participants receive DS-1040b 1.2 mg by intravenous infusion over six hours Receives: Drug: DS1040b
DS-1040b 2.4 mg	Experimental	Participants receive DS-1040b 2.4 mg by intravenous infusion over six hours Receives: Drug: DS1040b
DS-1040b 4.8 mg	Experimental	Participants receive DS-1040b 4.8 mg by intravenous infusion over six hours Receives: Drug: DS1040b
Placebo	Placebo comparator	Participants receive saline by intravenous infusion over six hours Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: 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
The PK parameter of maximum concentration (Cmax) was observed values.
Measured: 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
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.
Measured: 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
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
Measured: 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
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)
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 6 hours, 24 hours, and 48 hours post single, intravenous dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201719 Jan 2020

First posted26 Jun 2017
Study start30 Jul 2017
Primary completion19 Jan 2020
Study completion19 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind
Who is masked: Participant
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03198715
Sponsor's protocol ID: DS1040-A-J110
Other IDs: 173612
Status last verified: Jan 2021
First submitted: 19 Jun 2017
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35061236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Ischemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT03198715
Acronym / sponsor ID: DS1040-A-J110
Conditions: Acute Ischemic Stroke
Keywords: Fibrinolysis enhancer, TAFIa inhibitor, Developmental Phase I
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Jul 2017 (actual)
Primary completion: 19 Jan 2020 (actual)
Study completion: 19 Jan 2020 (actual)
First posted: 26 Jun 2017 (actual)
Results: Posted 28 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (participant)
Number of arms: 5

Arm	Type	Receives
DS-1040b 0.6 mg	Experimental	Drug: DS1040bParticipants receive DS-1040b 0.6 mg by intravenous infusion over six hours
DS-1040b 1.2 mg	Experimental	Drug: DS1040bParticipants receive DS-1040b 1.2 mg by intravenous infusion over six hours
DS-1040b 2.4 mg	Experimental	Drug: DS1040bParticipants receive DS-1040b 2.4 mg by intravenous infusion over six hours
DS-1040b 4.8 mg	Experimental	Drug: DS1040bParticipants receive DS-1040b 4.8 mg by intravenous infusion over six hours
Placebo	Placebo comparator	Drug: PlaceboParticipants receive saline by intravenous infusion over six hours

Who may qualify

Ages: 20 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DS1040bAlso: Investigational productDS-1040b in solution for intravenous infusion	Drug	DS-1040b 0.6 mg, DS-1040b 1.2 mg, DS-1040b 2.4 mg, DS-1040b 4.8 mg
PlaceboAlso: Saline solutionSaline solution for intravenous infusion	Drug	Placebo

Primary outcome

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.
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.

8 secondary outcomes

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
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
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
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
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
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
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
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

Results and safety

Results posted to the registry on 28 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DS-1040b 0.6 mg	6	6
DS-1040b 1.2 mg	12	11
DS-1040b 2.4 mg	12	10
DS-1040b 4.8 mg	3	3
Placebo	9	7

Primary outcome: 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. Count of participants. Unit: Participants

Measure	DS-1040b 0.6 mg n = 6	DS-1040b 1.2 mg n = 12	DS-1040b 2.4 mg n = 11	DS-1040b 4.8 mg n = 3	Placebo n = 9
Symptomatic ICH	0	0	0	0	0
Asymptomatic ICH	2	5	4	1	1
Hemorrhagic infarction type 1	0	1	0	0	0
Hemorrhagic infarction type 2	1	1	1	0	0
Parenchymal hematoma type 1	0	3	0	1	0
Parenchymal hematoma type 2	0	0	2	0	0
Not applicable	1	1	1	0	1

Population analysed: Bleeding events were assessed in the Safety Analysis Set.

Primary outcome: 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. Count of participants. Unit: Participants

Measure	DS-1040b 0.6 mg n = 6	DS-1040b 1.2 mg n = 12	DS-1040b 2.4 mg n = 11	DS-1040b 4.8 mg n = 3	Placebo n = 9
Value	0	0	0	0	0

Population analysed: Bleeding events were assessed in the Safety Analysis Set.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse event (TEAE) data were collected from start of treatment up to 30 days after last study dose, up to approximately 2 years 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DS-1040b 0.6 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
DS-1040b 1.2 mg	2 of 12 (16.7%)	10 of 12 (83.3%)	0 of 12
DS-1040b 2.4 mg	2 of 11 (18.2%)	10 of 11 (90.9%)	1 of 11
DS-1040b 4.8 mg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Placebo	1 of 9 (11.1%)	8 of 9 (88.9%)	2 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35061236Sakai 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Leader study director

Daiichi Sankyo

20 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DS1040b in people with Acute Ischemic Stroke, run by Daiichi Sankyo Co., Ltd. at 20 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03198715, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.