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Stroke drug bleeding risks revealed in new study

NCT ID NCT06337175

Knowledge-focused Sponsor: Kafrelsheikh University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study in 600 stroke patients in the Middle East looked at what factors might predict different types of brain bleeding after treatment with the clot-busting drug alteplase. Researchers analyzed patient characteristics, how quickly the drug was given, and stroke risk factors to see which ones were linked to bleeding. The goal was to better understand who is at higher risk, which could help doctors make safer treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
alteplase (a clot-busting drug)
What this could lead to
If successful, this could help doctors identify which stroke patients are at higher risk of brain bleeding after receiving alteplase, potentially improving treatment safety.
What could go wrong
This is a completed observational analysis, not a new treatment trial. The findings may not apply to all populations or change current guidelines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

600 people

The number who actually took part.

Started

Jun 2021

Finished

Apr 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The investigators enrolled individuals of both genders, aged between 18 and 75, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis. Exclusion Criteria: * The investigators excluded patients who had not been followed up on for 90 days after enrollment, * Those with alteplase contraindications or did not receive the total dose of alteplase due to any reason were excluded * The investigators excluded patients with a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis, history of head trauma with a residual neurological deficit). * The investigators excluded patients who had recurrent ischemic stroke diagnosed by appropriate clinical history and/or MRI brain findings. * The investigators excluded patients with symptoms of major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks. * The investigators also excluded pregnant and lactating patients with stroke due to venous thrombosis and stroke following cardiac arrest

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Conditions

The condition(s) this trial relates to.

ischemic stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alteplase adverse reaction Ischemic stroke

Contacts and locations

Locations

  • Kafr Elsheikh University Hospital

    Kafr ash Shaykh, 33155, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.