the Predictors of Hemorrhagic Transformation Subtypes in Acute Embolic Stroke Patients

NCT ID: NCT06653946

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 716 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-11-01

Brief Summary

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.

Conditions

Ischemic Stroke; Alteplase Adverse Reaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemorragic transformation group

262 acute ischemic stroke (AIS) patients who had a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase.

Group Type: ACTIVE_COMPARATOR

Alteplase

Intervention Type: DRUG

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

non-hemorragic transformation group

454 acute ischemic stroke (AIS) patients did not have a hemorrhagic transformation of brain infarction after 24-36 hours of receiving alteplase

Group Type: ACTIVE_COMPARATOR

Alteplase

Intervention Type: DRUG

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

Interventions

Alteplase

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

Intervention Type: DRUG

Alteplase

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

Intervention Type: DRUG

Other Intervention Names

group A; group B

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed G. zeinhom, MD

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed G. Zeinhom, MD

Role: PRINCIPAL_INVESTIGATOR

neurology department kafr el-sheikh university

Locations

Kafr Elsheikh University Hospital

Kafr ash Shaykh, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

mohamed G. Zeinhom, MD

Role: CONTACT

mohamed_gomaa@med.kfs.edu.eg

2001009606828

sherihan R. ahmed, MD

Role: CONTACT

sherihan_rezq@med.kfs.edu.eg

2001113432342

Facility Contacts

mohamed G. Zeinhom, MD

Role: primary

mohamed_gomaa@med.kfs.edu.eg

2001009606828

sherihan R. ahmed, MD

Role: backup

sherihan_rezq@med.kfs.edu.eg

2001007481842

References

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.

Reference Type: RESULT

PMID: 16731270 (View on PubMed)

Zeinhom 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.

Reference Type: RESULT

PMID: 34515113 (View on PubMed)

Bruno 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.

Reference Type: RESULT

PMID: 12221155 (View on PubMed)

Ahmed 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.

Reference Type: DERIVED

PMID: 40325067 (View on PubMed)

Other Identifiers

010120190

Identifier Type: -

Identifier Source: org_study_id