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Completed

NCT Number: NCT03198715

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

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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hirosaki University Hospital, Hirosaki, Aomori, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DS1040b

Drug

DS-1040b in solution for intravenous infusion

Other names: Investigational product

Placebo

Drug

Saline solution for intravenous infusion

Other names: Saline solution

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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)

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 26, 2017
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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