Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06360120
Other study ID # 00023098816
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 10, 2024
Est. completion date May 10, 2025

Study information

Verified date April 2024
Source Kafrelsheikh University
Contact mohamed G. Zeinhom, MD
Phone 2001009606828
Email mohamed_gomaa@med.kfs.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever large-vessel ischemic stroke patients treated with clopidogrel assessed through NIHSS, mRS, and possible adverse effects.


Description:

After the ethics committee of the faculty of medicine at Kafr el-Sheik University approves, the investigators will conduct a randomized controlled trial between April 2024 and April 2025. The investigators got written informed consent from all eligible patients or their first order of kin before randomization. The study will be composed of 2 arms atorvastatin arm, which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months, All the patients in the two groups received open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months. Study Procedures: Every patient in our study will undergo: Clinical workup: History, clinical assessment & NIHSS were recorded on admission, day 7, and the Modified Rankin Scale as a follow-up after one week and 3 months. Detection of Risk Factors & Profiles: Echocardiography& TOE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. - Carotid Duplex: carotid duplex in indicated patients. 4- ESR & Lipid Profile& liver functions: All will be tested routinely for all patients. Every patient underwent CT brain and MRI brain using stroke protocol: T1W, T2W, FLAIR, DWI, T2 Echo Gradient, CTA, or MRA (if CTA was contraindicated), from the aortic arch through the circle of Willis. Two neuroradiologists blinded to treatment reviewed C.T. and MRI source images. Cerebrovascular vessels were divided into segments: supra-clinoid internal carotid artery, first-division middle cerebral artery (M1), second-division middle cerebral artery (M2), basilar artery (B.A.), intracranial vertebral artery (V.A.). A neuroradiologist determined whether any of these vascular segments were occluded. If there was no vascular occlusion, the patient was documented as having no large vessel occlusion. If one or more vascular segments were occluded and the patient was ineligible for thrombectomy or arterial stenting, the case history and NIHSS score were reviewed; if the vascular occlusion was in the appropriate territory to account for the clinical findings, the case was judged as having a large-vessel occlusion Primary End Point: The primary efficacy outcome was the rate of new stroke at 90 days • Secondary End Point: the secondary efficacy outcomes were to evaluate the rates of patients who achieved a significant reduction in NIHSS (decrease of four points or more) at the seventh day or discharge compared to baseline, the rates of a favorable outcome with (mRS = 0-2) after one week and after 90 days in a face-to-face interview in the outpatient clinic, rates of the composite of recurrent stroke, myocardial infarction, and death due to vascular events after 90 days of follow-up, while the secondary safety outcome was the rate of treatment-related acute liver injury assessed by ALT, AST test at 90 days, statin-induced myopathy assessed by CPK at 90 days and other adverse effects assessed by a follow-up questionnaire.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date May 10, 2025
Est. primary completion date April 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - males and females aged 18-75 first-ever large-vessel acute ischemic stroke Exclusion Criteria: - We excluded patients with allergies to any of the studied drugs or who suffered from clinical seizures as a part of their stroke, those with major organ failure, malignancies, or myocardial infarction during the past six weeks, and patients who administered regular antiplatelet or anticoagulant in the previous week to avoid clouding our drug safety assessment. We excluded patients with a minor stroke (National Institutes of Health Stroke Scale (NIHSS) = 3) or severe stroke (NIHSS = 25), patients who had spontaneous resolution of symptoms before imaging, and patients with a history of a CNS disorder (e.g., multiple sclerosis, epilepsy, meningioma). Patients were also not eligible if carotid, cerebrovascular, or coronary revascularization was planned, requiring halting study treatment within seven days after randomization. Patients who experienced a cardioembolic stroke either prior to or post-treatment were not included in our study. Cardio-embolic strokes were diagnosed when the patient exhibited potential conditions to have a cardiac source of emboli such as mechanical cardiac valves, atrial fibrillation (AF), mitral valve prolapse, aortic valve stenosis or calcification, and patent foramen ovale . The patient was diagnosed with clinical AF based on the presence of a conventional 12-lead electrocardiography (ECG) recording that exhibited a minimum of 30 seconds of cardiac rhythm, showing the absence of identifiable recurring P waves and irregular RR intervals (when atrioventricular conduction is not impaired). We excluded patients with a source of gastrointestinal bleeding such as peptic ulcers, patients with recurrent stroke based on appropriate clinical history, examination, and/or MRI brain findings, and those who had a blood glucose level < 50 or > 400 mg/DL or Platelet count < 100,000 or international normalized ratio > 1.4 or Prothrombin time >18. We excluded patients who were regular users of drugs that affected clopidogrel metabolism, such as proton pump inhibitors, ketoconazole, dihydropyridine calcium channel blockers, and rifampin. We excluded pregnant or lactating females, patients with venous infarction, and ischemic infarction secondary to hypo-perfusion.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atorvastatin 40 Mg Oral Tablet
The atorvastatin group consisted of 300 patients who received 40 mg daily atorvastatin for 3 months, and open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.
Rosuvastatin 20mg
The rosuvastatin group consisted of 300 patients who received 40 mg daily rosuvastatin for 3 months, and open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months.

Locations

Country Name City State
Egypt Kafr Elsheikh University Hospital Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

Paciaroni M, Ince B, Hu B, Jeng JS, Kutluk K, Liu L, Lou M, Parfenov V, Wong KSL, Zamani B, Paek D, Min Han J, Del Aguila M, Girotra S. Benefits and Risks of Clopidogrel vs. Aspirin Monotherapy after Recent Ischemic Stroke: A Systematic Review and Meta-An — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the rate of new stroke at 90 days Rates of new ischemic stroke occur within three months of treatment. The investigators will perform follow-ups of the patient during visits to the outpatient clinic, and brain CT and/ or MRI will be done if there is suspicion of recurrence of ischemic stroke 90 days
Secondary Value of National Institute of Health Stroke Scale (NIHSS) after one week NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke and aid in planning post-acute care disposition.
It ranges from 0 to 42; the lower the score, the better the stroke condition. Improvement will be counted only if the NIHSS score decreases by four points or more within one week of stroke onset.
7 days
Secondary value of Modified Rankin Scale (mRS) at one week mRS Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability its value ranges from 0 to 6; the lower the score, the better the stroke outcome favorable stroke outcome is considered with mRS value equals two or less. 7 days
Secondary value of Modified Rankin Scale(mRS) at three months mRS Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability its value ranges from 0 to 6; the lower the score, the better the stroke outcome favorable stroke outcome is considered with mRS value equals two or less. 3 months
Secondary rate of composite recurrent stroke, myocardial infarction, and death due to vascular events rates of new ischemic stroke, TIA, myocardial infarction, or death from vascular events within three months of treatment the investigators will perform follow-ups of the patient during visits to the outpatient clinic and perform needed investigations such as brain imaging, Electrocardiography, arterial and venous duplex ultrasound imaging. 3 months
Secondary rate of drug adverse effects Drug adverse effects: all side effects related to the drugs of our study will be reported 90 days
Secondary Drug adverse effects: all side effects related to the drugs of our study will be reported the rate of drug hemorrhagic complications which was evaluated using the PLATO bleeding definition which classified hemorrhagic complications into three types as follows: Major bleeding which had one or more of the following criteria: fatal bleeding, intracranial, intrapericardial, bleeding associated with reduction of hemoglobin > 3-5 g/dl, bleeding required transfusion of two to four units whole blood or PRBCs, bleeding produced hypovolemic shock or severe hypotension that required pressor or surgery; Minor bleeding that required medical intervention to stop or treat bleeding: Minimal bleeding: any bleeding that did not require intervention or treatment such as bruising, bleeding gums, oozing from injection sites. 90 days
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05518305 - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT03728738 - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke Phase 3
Terminated NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Not yet recruiting NCT06032819 - Differentiating Between Brain Hemorrhage and Contrast
Not yet recruiting NCT06026696 - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2
Completed NCT01983644 - RECO Flow Restoration Device Versus Solitaire FR With the Intention for Thrombectomy Study N/A