Ischemic StrokePhase 4NCT06058884
Predictors of AIS Unfavorable Outcomes
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 whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes. 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
- 592 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2022to 29 Jun 2023
- 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, who presented with acute first-ever ischemic stroke and were eligible for thrombolysis.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictors of the Unfavourable Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase, a Multi-centre Prospective Study
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.
Read the detailed description
Investigators conducted a prospective cohort study between January 2022 and June 2023 and screened 1184 patients presented with AIS and received alteplase and included 592 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 mRS after 90 days via a 10-minute telephone interview. With patients or their primary caregivers to detect the score, all of our patients had baseline mRS of zero. mRS two or less was considered a favourable outcome
The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes, while the second group comprised 136 patients who experienced unfavourable outcomes.
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.
- Conditions
- Ischemic Stroke, Alteplase Adverse Reaction
- Being tested
- Alteplase
- Keywords
- alteplase, acute ischemic stroke, Egypt, Saudi Arabia
- 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
Following the guidelines set forth 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 |
|---|---|---|
| favourbale outcome group | Active comparator | Four hundred fifty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) two or less after 90 days of ischemic stroke. Receives: Drug: Alteplase |
| unfavourbale outcome group | Active comparator | One hundred thirty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) three or more after 90 days of ischemic stroke. Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin scale (mRS)
To detect the score, investigators assessed modified rankin scale (mRS) after 90 days via a 10-minute telephone interview with patients or their primary caregivers. mRS two or less was considered a favourable outcome.
mRS is a scale that assessed the outcome of stroke patients and its score ranged from zero to six. the lower the values the better the outcome
Measured: 90 days
predictors of the unfavourable outcomes
The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict the unfavourable outcomes after 90 days of acute ischemic stroke.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start3 Jan 2022
- Primary completion3 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes (mRS two or less), while the second group comprised 136 patients who experienced unfavourable outcomes (mRS more than two).
- Masking
- None (open label)
- Enrolment
- 592 participants (actual)
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,PHD, Principal investigator, neurology department kafr el-sheikh university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058884
- Sponsor's protocol ID
- 23091988
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 10 Oct 2023
- 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 12221155Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.
PubMed 36446950Ahmed SR, Mohamed AAM, Salem HH, Helmy S, Moustafa RR, Borham SMF. Association of white matter hyperintensities with migraine phenotypes and response to treatment. Acta Neurol Belg. 2023 Oct;123(5):1725-1733. doi: 10.1007/s13760-022-02015-x. Epub 2022 Jul 19.
PubMed 35854172Zeinhom MG, Khalil MFE, Kamel IFM, Kohail AM, Ahmed SR, Elbassiouny A, Shuaib A, Al-Nozha OM. Predictors of the unfavorable outcomes in acute ischemic stroke patients treated with alteplase, a multi-center randomized trial. Sci Rep. 2024 Mar 12;14(1):5960. doi: 10.1038/s41598-024-56067-5.
PubMed 38472241
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of the Unfavourable Outcomes in Acute Ischemic Stroke Patients Treated With Alteplase, a Multi-centre Prospective Study
- ClinicalTrials.gov ID
- NCT06058884
- Acronym / sponsor ID
- 23091988
- Conditions
- Ischemic Stroke, Alteplase Adverse Reaction
- Keywords
- alteplase, acute ischemic stroke, Egypt, Saudi Arabia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 28 Sep 2023 (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 whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.
Detailed description
Investigators conducted a prospective cohort study between January 2022 and June 2023 and screened 1184 patients presented with AIS and received alteplase and included 592 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 mRS after 90 days via a 10-minute telephone interview. With patients or their primary caregivers to detect the score, all of our patients had baseline mRS of zero. mRS two or less was considered a favourable outcome
The study consisted of two distinct groups. The first group consisted of 456 patients who experienced favourable outcomes, while the second group comprised 136 patients who experienced unfavourable outcomes.
The investigators evaluated whether the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors were predictive variables for unfavourable outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 consisted of 456 patients who experienced favourable outcomes (mRS two or less), while the second group comprised 136 patients who experienced unfavourable outcomes (mRS more than two).
| Arm | Type | Receives |
|---|---|---|
| favourbale outcome group | Active comparator | Drug: AlteplaseFour hundred fifty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) two or less after 90 days of ischemic stroke. |
| unfavourbale outcome group | Active comparator | Drug: AlteplaseOne hundred thirty-six acute ischemic stroke (AIS) patients who had modified Rankin scale (mRS) three or more after 90 days of ischemic stroke. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| AlteplaseFollowing the guidelines set forth 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 | favourbale outcome group, unfavourbale outcome group |
Primary outcome
modified Rankin scale (mRS)
Time frame: 90 days
To detect the score, investigators assessed modified rankin scale (mRS) after 90 days via a 10-minute telephone interview with patients or their primary caregivers. mRS two or less was considered a favourable outcome. mRS is a scale that assessed the outcome of stroke patients and its score ranged from zero to six. the lower the values the better the outcome
predictors of the unfavourable outcomes
Time frame: 90 days
The investigators employed univariate and multivariate Logistic regression analysis to assess the ability of patients' characteristics and risk factors to predict the unfavourable outcomes after 90 days of acute ischemic stroke.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- 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.
- Results publication: PubMed 36446950Aref HM, El-Khawas H, Elbassiouny A, Shokri HM, Zeinhom MG, Roushdy TM. A randomized pilot study of the efficacy and safety of loading ticagrelor in acute ischemic stroke. Neurol Sci. 2023 Feb;44(2):765-771. doi: 10.1007/s10072-022-06525-7. Epub 2022 Nov 30.
- Results publication: PubMed 35854172Ahmed SR, Mohamed AAM, Salem HH, Helmy S, Moustafa RR, Borham SMF. Association of white matter hyperintensities with migraine phenotypes and response to treatment. Acta Neurol Belg. 2023 Oct;123(5):1725-1733. doi: 10.1007/s13760-022-02015-x. Epub 2022 Jul 19.
- Derived from this study: PubMed 38472241Zeinhom MG, Khalil MFE, Kamel IFM, Kohail AM, Ahmed SR, Elbassiouny A, Shuaib A, Al-Nozha OM. Predictors of the unfavorable outcomes in acute ischemic stroke patients treated with alteplase, a multi-center randomized trial. Sci Rep. 2024 Mar 12;14(1):5960. doi: 10.1038/s41598-024-56067-5.
- 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.
Related trials for Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
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,PHD 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 1 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: finished, as of the sponsor's last update on 10 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin scale (mRS) (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT06058884, which also lists 6 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 10 Oct 2023.