Ischemic StrokePhase 4NCT06653946
the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients
A Phase 4 study testing Alteplase in people with Ischemic Stroke and Alteplase Adverse Reaction, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke, Alteplase Adverse Reaction
- What is being tested?
- Alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 716 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The investigators enrolled individuals of both genders, aged between 18 and 75,
- All patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis.
- All patients had Atrial fibrillation
Who cannot join
- The investigators excluded patients who had alteplase contraindications
- The investigators excluded patients who did not receive the total dose of alteplase for any reason.
- The investigators excluded patients who had a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis)
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kafr Elsheikh University Hospital
Kafr ash Shaykh, 33511
mohamed G. Zeinhom, MD, 2001009606828, mohamed_gomaa@med.kfs.edu.eg
sherihan R. ahmed, MD, 2001007481842, sherihan_rezq@med.kfs.edu.eg
About this study
Official title: the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase
The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
Read the detailed description
Investigators conducted a prospective cohort study between July 2021 and July 2023. They screened 1550 patients who presented with AIS and received alteplase and included 716 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.
The investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.
The study consisted of two distinct groups. The first group consisted of 454 patients who did not experience hemorrhagic infarction, while the second group comprised 262 patients who experienced hemorrhagic infarction.
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors different types of AF were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
- Conditions
- Ischemic Stroke, Alteplase Adverse Reaction
- Being tested
- Alteplase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called group A
Following the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit
AlteplaseDrug
Also called group B
Following the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit
| Study group | Role | What they receive |
|---|---|---|
| Hemorragic transformation group | Active comparator | 262 acute ischemic stroke (AIS) patients who had a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase. Receives: Drug: Alteplase |
| non-hemorragic transformation group | Active comparator | 454 acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
Measured: 48 days
Secondary outcomes (3)
the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group
The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group
Measured: 48 hours
the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group
The investigators will evaluate the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group
Measured: 48 hours
the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group
The investigators will evaluate the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2024
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study consisted of two distinct groups. The first group comprised 454 patients who did not experience hemorrhagic infarction, while the second group comprised 252 patients who experienced hemorrhagic infarction.
- Masking
- None (open label)
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed G. zeinhom, MD, Kafrelsheikh University
- Investigators
- mohamed G. Zeinhom, MD, Principal investigator, neurology department kafr el-sheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653946
- Sponsor's protocol ID
- 010120190
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All the data supporting this research's findings may be available from the principal investigator, Mohamed G. Zeinhom, upon reasonable request.
Publications
Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.
PubMed 16731270Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.
PubMed 34515113Bruno A, Levine SR, Frankel MR, Brott TG, Lin Y, Tilley BC, Lyden PD, Broderick JP, Kwiatkowski TG, Fineberg SE; NINDS rt-PA Stroke Study Group. Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke Trial. Neurology. 2002 Sep 10;59(5):669-74. doi: 10.1212/wnl.59.5.669.
PubMed 12221155Ahmed SR, Zeinhom MG, Ebied AAMK, Kamel IFM, Almoataz MA, Daabis AMA, Akl AZO, Mahmoud ELA, Alkhalefeh AG, Ouf SG, Mosbah SAA, Sirag IMI, Abouelnaga M, Khalil MFE. A multi-center study on the predictors of different subtypes of hemorrhagic transformation of brain infarction after thrombolysis in atrial fibrillation patients presented with embolic stroke. Sci Rep. 2025 May 5;15(1):15655. doi: 10.1038/s41598-025-97968-3.
PubMed 40325067
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase
- ClinicalTrials.gov ID
- NCT06653946
- Acronym / sponsor ID
- 010120190
- Conditions
- Ischemic Stroke, Alteplase Adverse Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators evaluated the impact of AF on different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
Detailed description
Investigators conducted a prospective cohort study between July 2021 and July 2023. They screened 1550 patients who presented with AIS and received alteplase and included 716 AIS patients who met the inclusion criteria and were diagnosed based on a thorough clinical assessment, including a detailed medical history, physical examination, and specific brain imaging results and treated with alteplase within four and half hours of stroke onset.
The investigators assessed the patients' follow-up brain imaging to detect the subtypes of hemorrhagic transformation after receiving alteplase.
The study consisted of two distinct groups. The first group consisted of 454 patients who did not experience hemorrhagic infarction, while the second group comprised 262 patients who experienced hemorrhagic infarction.
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors different types of AF were predictive variables for different subtypes of post-alteplase hemorrhagic transformation of brain infarction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study consisted of two distinct groups. The first group comprised 454 patients who did not experience hemorrhagic infarction, while the second group comprised 252 patients who experienced hemorrhagic infarction.
| Arm | Type | Receives |
|---|---|---|
| Hemorragic transformation group | Active comparator | Drug: Alteplase262 acute ischemic stroke (AIS) patients who had a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase. |
| non-hemorragic transformation group | Active comparator | Drug: Alteplase454 acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The investigators enrolled individuals of both genders, aged between 18 and 75,
- All patients had acute first-ever embolic ischemic stroke and were eligible for thrombolysis.
- All patients had Atrial fibrillation
Key exclusion criteria (6 listed)
- The investigators excluded patients who had alteplase contraindications
- The investigators excluded patients who did not receive the total dose of alteplase for any reason.
- The investigators excluded patients who had a known history of persistent or recurrent CNS pathology (e.g., epilepsy, meningioma, multiple sclerosis)
- 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.
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 |
|---|---|---|
| AlteplaseAlso: group AFollowing the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit | Drug | Hemorragic transformation group |
| AlteplaseAlso: group BFollowing the guidelines set by the American Heart Association/American Stroke Association (AHA/ASA), inclusion and exclusion criteria for alteplase were established; 0.9 mg/kg of alteplase up to a maximum dose of 90 mg was administered intravenously to eligible individuals within 4.5 hours of the beginning of their clinical manifestations (10% bolus, 90% infusion in 1 hour). After receiving IV-alteplase, all patients continued their management and rehabilitation in the stroke unit | Drug | non-hemorragic transformation group |
Primary outcome
the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
Time frame: 48 days
The investigators will evaluate the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group
3 secondary outcomes
the rate of each AF type in the hemorrhagic infarction type 2 group compared to non HT group
Time frame: 48 hours
the rate of each AF type in the parenchymal haematoma type 1 group compared to non HT group
Time frame: 48 hours
the rate of each AF type in the parenchymal haematoma type 2 group compared to non HT group
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: PubMed 16731270Lopez AD, Mathers CD, Ezzati M, Jamison DT, Murray CJ. Global and regional burden of disease and risk factors, 2001: systematic analysis of population health data. Lancet. 2006 May 27;367(9524):1747-57. doi: 10.1016/S0140-6736(06)68770-9.
- Results publication: PubMed 34515113Zeinhom MG, Aref HM, El-Khawas H, Roushdy TM, Shokri HM, Elbassiouny A. A pilot study of the ticagrelor role in ischemic stroke secondary prevention. Eur Neurol. 2022;85(1):50-55. doi: 10.1159/000518786. Epub 2021 Aug 30.
- Results publication: PubMed 12221155Bruno A, Levine SR, Frankel MR, Brott TG, Lin Y, Tilley BC, Lyden PD, Broderick JP, Kwiatkowski TG, Fineberg SE; NINDS rt-PA Stroke Study Group. Admission glucose level and clinical outcomes in the NINDS rt-PA Stroke Trial. Neurology. 2002 Sep 10;59(5):669-74. doi: 10.1212/wnl.59.5.669.
- Derived from this study: PubMed 40325067Ahmed SR, Zeinhom MG, Ebied AAMK, Kamel IFM, Almoataz MA, Daabis AMA, Akl AZO, Mahmoud ELA, Alkhalefeh AG, Ouf SG, Mosbah SAA, Sirag IMI, Abouelnaga M, Khalil MFE. A multi-center study on the predictors of different subtypes of hemorrhagic transformation of brain infarction after thrombolysis in atrial fibrillation patients presented with embolic stroke. Sci Rep. 2025 May 5;15(1):15655. doi: 10.1038/s41598-025-97968-3.
- Individual participant dataSharing planned: No. All the data supporting this research's findings may be available from the principal investigator, Mohamed G. Zeinhom, upon reasonable request.
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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.
mohamed G. Zeinhom, MD principal investigator
neurology department kafr el-sheikh university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alteplase in people with Ischemic Stroke and Alteplase Adverse Reaction, run by Kafrelsheikh University at 1 site in Egypt.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed G. Zeinhom, MD (2001009606828, mohamed_gomaa@med.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of each AF type in the hemorrhagic infarction type 1 group compared to non HT group (time frame: 48 days). 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 NCT06653946, which also lists 4 linked publications.
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 29 Oct 2024.