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RecruitingNCT06248242TASPEUpdated Feb 8, 2024

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

A Phase 4 interventional study of Edaravone dexborneol in Acute Ischemic Stroke, sponsored by The Second Hospital of Hebei Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by The Second Hospital of Hebei Medical University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Registered 2 years 7 months after the study started (first participant enrolled Jun 2021, registered Jan 2024).
  • Started Jun 2021; still recruiting 5 years 5 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Acute Ischemic Stroke

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Keywords

  • Edaravone dexborneol
  • recombinant tissue-type plasminogen activator
  • Acute cerebral infarction
03

In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 400 is above the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

The Second Hospital of Hebei Medical University is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
400 participants (estimated)

Study arms

  • 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

Interventions

  • DrugEdaravone dexborneol

    Drug pages: Edaravone · Dexborneol

    edaravone 10 mg and dexborneol 2.5 mg twice daily

06

What researchers measure

Primary outcomes

  1. Comparison of neurological function between the two groups

    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.

    Time frame: baseline, day 12 and month 3

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Jun 2024, 36 months after the start.

Of 74 non-industry phase 4 interventional studies under Ischemic Stroke, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 41. This study's planned 36 months is above that.

Counting every sponsor, half of 83 studies reached it within 31 months; a quarter within 24 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 17, 2024
First posted
Feb 8, 2024
StartActual
Jun 1, 2021
Primary completionEst.
Jun 30, 2024
CompletionEst.
Jun 30, 2024
Last update
Feb 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06248242
Lead sponsor
The Second Hospital of Hebei Medical University
Responsible party
Sponsor
First posted
Feb 8, 2024
Start date
Jun 1, 2021
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Feb 8, 2024

Study contacts

Guojun Tan, Dr
Contact
tandyshine@163.com
15803210587
Boxu Xie
Contact
xiebx1999@163.com
15383935253
Guojun Tan, Dr
study chair · The Second Hospital of Hebei Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Edaravone · Dexborneol

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