Treatment of Acute Ischemic Stroke With Rt-PA Combined With Edaravone Dexborneol (TASPE)

January 30, 2024 updated by: The Second Hospital of Hebei Medical University

A Multicenter, Randomized, Controlled Study of Rt-PA Thrombolysis Combined With Edaravone Dexborneol in Reducing Hemorrhagic Transformation in Patients With Acute Ischemic Stroke

In this study, a multicenter, randomized, controlled, prospective cohort study was conducted to observe the effect of Edaravone Dexborneol on the incidence and outcome of bleeding transformation after thrombolysis in acute ischemic stroke. To explore the methods to reduce the dilemma of bleeding transformation after thrombolysis, and to dynamically detect the changes of the main links causing bleeding transformation such as blood-brain barrier damage, local immune response activation and so on. To explore the mechanism of Edaravone Dexborneol in reducing bleeding transformation. It is proved that Edaravone Dexborneol combined with thrombolytic therapy can reduce the risk of bleeding and transformation after thrombolysis and improve the safety of thrombolysis. Secondly, it can improve the early recanalization rate of ischemic stroke patients after thrombolytic therapy, and effectively protect the integrity of the blood-brain barrier.

Study Overview

Status

Status

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

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.

Detailed Description

Acute cerebral infarction is an ischemic disease caused by the narrowing or blockage of cerebral blood vessels, which can lead to a series of complications such as progressive brain tissue damage and deterioration of neurological function. According to epidemiological surveys, acute cerebral infarction is the second deadliest disease in the world, with a rapid onset, rapid progression, high disability rate, and high mortality rate. In clinical work, it was found that many patients with acute cerebral infarction experienced a further exacerbation of symptoms; this is clinically known as a progressive stroke. The progressive stroke is a type of cerebral infarction in which the neurological impairment is progressively aggravated after the onset of the disease or after clinical treatment. Patients and their families are often unable to understand and accept such changes in their condition, and therefore, effectively blocking the progression of the acute-phase of cerebral infarction has become one of the most problematic situations during the course of clinical treatment.

Currently, the clinically preferred treatment option for patients with acute cerebral infarction is revascularization therapy, in which rt-PA can open the blood vessels at the first time to restore the blood supply to ischemic brain tissues. However, the effect of rt-PA thrombolysis decreases with the passage of the time from drug application, which often leads to a low rate of recanalization as well as other uncertainties. Only a few patients are benefited, and the condition in a small number of patients does not improve significantly after thrombolysis, and disease even progresses. Therefore, the timely application of other drugs after thrombolysis is particularly important.

The pathogenesis of cerebral infarction has not yet been fully elucidated. However, the mechanisms of carotid atheromatous plaque formation, oxidative stress, and inflammation are widely recognized, and the above mechanisms are interconnected. Studies have shown that after acute cerebral infarction, neuronal cells may suffer from ischemia and hypoxia, leading to apoptosis and a large accumulation of reactive oxygen species, which triggers an immunoinflammatory response and exacerbates brain tissue damage. Brain tissue damage will be exacerbated by the immunoinflammatory response. Recent studies have also found that abnormal glucose metabolism plays a crucial role in the pathogenesis of acute cerebral infarction, and that abnormal glucose metabolism accelerates the course of disease, promoting the production of inflammation, reactive oxygen species (ROS), and other substances, which affects disease progression.

The edaravone dexborneol Concentrated Solution for Injection is composed of edaravone and dexborneol in a 4:1 ratio. Edaravone is a free radical scavenger and can effectively remove the accumulation of free radicals after acute cerebral infarction, impede disease progression, and improve the prognosis of cerebral infarction. Dexborneol is a naturally occurring terpene bicyclic organic compound. Dexborneol is anti-inflammatory and can effectively inhibit inflammatory cytokines. The combination of both of them can cut off the pathway between the free radicals and the inflammation, and effectively prevents the disease progression caused by the oxidative stress and inflammation that otherwise leads to disease development.

The timely use of drugs after thrombolysis can effectively improve patients' neurological impairment. Therefore, we explored the clinical efficacy of rt-PA combined with edaravone and dexborneol for the treatment of acute cerebral infarction, to clarify whether their combined use could improve cerebral blood supply of patients through the reconstruction of the blood. This study also sought to determine the mechanism of action of edaravone and dexborneol to guide the selection of therapies for cerebral infarction and improve the patient outcomes.

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 (Estimated)

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.
400

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.
  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guojun Tan

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. All patients met the diagnostic criteria of the Chinese acute ischemic stroke diagnosis and treatment guidelines.
  2. Patients developed clinical symptoms for the first time, with an onset time of less than 4.5 hours.
  3. Patients with the National Institutes of Health Stroke Scale (NIHSS) neurological deficit score was ≥4.
  4. The study was approved by the hospital's theoretical committee and the patients provided consent.

Exclusion Criteria:

  1. Patients were allergic to the drugs used in this study.
  2. Patients with a history of intracranial hemorrhage or subarachnoid hemorrhage, a recent history of head trauma, myocardial infarction, hemorrhage, and major surgical surgery
  3. Patients with cerebral hemorrhage and large-area imaging cerebral infarction characteristics
  4. Patients with severe infection, immune system and blood system diseases
  5. Patients with severe injury to other important organs
  6. Patients with severe coma or mental disorders
  7. Patients undergoing surgical treatment within 2 weeks

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: Parallel Assignment
  • Masking: Double

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.
No Intervention: The control group
The control group received basic treatment following intravenous drip of rt-PA (specification: 50 mg), including statins and drugs that improve circulation.
Experimental: The edaravone dexborneol group
The edaravone dexborneol group received an injection of concentrated edaravone dexborneol solution (specifications: edaravone, 10 mg and dexborneol, 2.5 mg in a 5 mL solution) and 0.9% sodium chloride injection [(100 mL), intravenous infusion twice per day, completed within 30 minutes]. The time between the two doses was no less than 6 hours, and each cycle lasted 12 days.
Drug: Edaravone dexborneol
edaravone 10 mg and dexborneol 2.5 mg twice daily

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
Comparison of neurological function between the two groups
Time Frame: baseline, day 12 and month 3
The NIHSS score will be evaluated in both groups on the first day of admission, and at 12 days and 3 months of follow-up. The higher the score, the more serious the neurological function defect, and the less effective the treatment.
baseline, day 12 and month 3

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.
The Second Hospital of Hebei Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Guojun Tan, Dr, The Second Hospital of Hebei Medical University

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.
June 1, 2021

Primary Completion (Estimated)

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.
June 30, 2024

Study Completion (Estimated)

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.
June 30, 2024

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).
January 17, 2024

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.
January 30, 2024

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.
February 8, 2024

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.
February 8, 2024

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 30, 2024

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.
December 1, 2023

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.
  • 2021-C022
  • No. P-KJ-QT-210009 (Other Grant/Funding Number: CSA Cerebrovascular Disease Innovation Medical Research Fund)

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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