A Phase 3 interventional study of Clopidogrel tablet and Cilostazol 100 MG in Ischemic Stroke, sponsored by Kafrelsheikh University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Kafrelsheikh University · Phase 3, Interventional, and Treatment
Along with the current clinical trial, the efficacy and safety of a 300 mg loading dose of clopidogrel administered within 24 hours of the first-ever moderate to severe ischemic stroke compared to 200 mg cilostazol were assessed through NIHSS, mRS, and possible adverse effects.
The investigators conducted a single-blinded randomized controlled trial after approval of the ethics committee of the faculty of medicine at Kafr el-Sheik University.
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 clopidogrel arm, which consisted of 435 patients who received a 300 mg loading dose followed by 75 mg once daily from the 2nd to the 90th day), and the cilostazol arm, consisting of 435 patients who received (a 200 mg loading dose during the first 24 hours of stroke onset followed by 100 mg twice daily from the 2nd day to the 90th day),
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 TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients.
4- ESR \& Lipid Profile\& liver functions: All will be tested routinely for all patients.
Imaging Follow-UP Non-contrast CT brain on admission Day 2 MRI: after 2 days of admission, all the patients in this study will have a brain MRI (stroke protocol; T1W, T2W, FLAIR, DWI, T2 Echo Gradient, MRA of all intra-cerebral vessels).
CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT.
Primary End Point:
The primary efficacy outcome was the rate of new stroke at 90 days, and the primary safety outcome was the rate of drug hemorrhagic complications using the PLATO bleeding definition.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 870 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
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Exclusion Criteria:
The investigators excluded patients who had clinical seizures at the onset of their stroke, as well as those who had symptoms of any major organ failure, active malignancies, or an acute myocardial infarction within the previous six weeks, and those who were on warfarin, regular ticagrelor during the week before admission, or chemotherapy within the previous year.
The investigators excluded patients with active peptic ulcers, GIT surgery, bleeding history within the last year, and those with a history of major surgery within the last three months.
The investigators ruled out of our trial patients who had a known allergy to the study drugs and those with INR > 1.4 or P.T. >18 or blood glucose level \< 50 or > 400 mg/DL or blood pressure \< 90/60 or > 185/110 mmHg on admission or Platelets \< 100,000.
The investigators excluded pregnant and lactating patients and those with stroke due to venous thrombosis and stroke following cardiac arrest or profuse hypotension ineligible for our trial.
Patients with contraindications to the study drugs were excluded.
The clopidogrel arm will receive (a 300 mg loading dose during the first 24 hours of stroke onset, followed by 75 mg daily from the 2nd to the 90th day)
Drug: Clopidogrel tablet
The cilostazol arm will receive (a 200 mg loading dose during the first 24 hours of stroke onset, followed by 100 mg twice daily from the 2nd day to the 90th day)
Drug: Cilostazol 100 MG
Efficacy and safety of a 300mg loading dose of clopidogrel administered within 24 hours of first-ever ischemic stroke followed by 75mg daily for 3 months will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects.
Also known as: group A
Efficacy and safety of 200 mg cilostazole followed by 100 mg twice daily for 3 months will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects.
Also known as: group B
rate of new stroke
Rates of new 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 new stroke.
Time frame: 90 days
Rate of drug-related hemorrhagic complications
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.
Time frame: 90 days
Rate of new ischemic stroke at 90 days
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 new ischemic stroke. It ranges from 0 to 42; the lower the score, the better the stroke condition. The improvement will be counted only if there is a decrease in NIHSS score by four points or more within one week of stroke onset.
Time frame: 90 days
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. A favorable stroke outcome is considered with mRS value equal to two or less.
Time frame: 3 months
rate of composite recurrent stroke, myocardial infarction, and death due to vascular events
Rates of new 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
Time frame: 3 months
rate of drug adverse effects
Drug adverse effects: all side effects related to the drugs of our study will be reported
Time frame: 90 days
Plan to share: No — All the data that support the findings of this research will be available from the corresponding author M. Zeinhom upon reasonable request.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Kafrelsheikh University