Evaluating factors affecting bleeding in stroke patients treated with alteplase
the Predictors of Different ECASS-based Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients Treated With Alteplase
PHASE4 · Kafrelsheikh University · NCT06653946
This study is trying to see how atrial fibrillation affects bleeding in stroke patients who are treated with alteplase.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 716 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Kafr ash Shaykh) |
| Trial ID | NCT06653946 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of atrial fibrillation on different subtypes of hemorrhagic transformation in patients who have experienced an acute ischemic stroke and received alteplase treatment. Conducted as a prospective cohort study, it screened 1550 patients and included 716 who met the criteria, focusing on their clinical assessments and follow-up brain imaging. The research aims to identify predictive variables related to the characteristics of ischemic stroke patients, door-to-needle time, and stroke risk factors that may influence the occurrence of hemorrhagic transformation post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a first-ever embolic ischemic stroke and a diagnosis of atrial fibrillation eligible for thrombolysis.
Not a fit: Patients with contraindications to alteplase, recurrent ischemic strokes, or significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management strategies for stroke patients receiving alteplase.
How similar studies have performed: Other studies have explored hemorrhagic transformation in stroke patients, but this specific focus on atrial fibrillation and its predictive factors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Kafr ash Shaykh
- Kafr Elsheikh University Hospital — Kafr ash Shaykh, Egypt (RECRUITING)
Study contacts
- Principal investigator: mohamed G. Zeinhom, MD — neurology department kafr el-sheikh university
- Study coordinator: mohamed G. Zeinhom, MD
- Email: mohamed_gomaa@med.kfs.edu.eg
- Phone: 2001009606828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Alteplase Adverse Reaction