A Phase 3 interventional study of Ticagrelor 90 MG Oral Tablet and Clopidogrel tablet 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 2024-05-14.
Sponsored by Kafrelsheikh University · Phase 3, Interventional, and Treatment
Along with the current clinical trial, the efficacy and safety of 180 mg loading dose of ticagrelor administered within the first 24 hours of first-ever ischemic stroke compared to 300 mg clopidogrel were assessed through NIHSS, mRS, duration of hospital stay, and possible adverse effects.
The investigators will conduct a single-blinded randomized controlled trial between October 2022 and December 2023 after approval of the ethical 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 ticagrelor arm, which consisted of 450 patients who received a 180 mg loading dose followed by 90 mg b.i.d from the 2nd to the 90th day), and the Clopidogrel arm consisting of 450 patients who received (a 300 mg loading dose during the first 24 hours of stroke onset followed by 75 mg once daily from the 2nd day to the 90th day)
Study Procedures:
Every patient in our study will undergo:
Detection of Risk Factors \& Profiles:
4- ESR \& Lipid Profile\& liver functions: All will be tested routinely for all patients.
Imaging Follow UP
The primary efficacy outcome was the rate of new ischemic 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 900 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Kafrelsheikh University is the lead sponsor of 285 studies on the registry; 110 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: The investigators excluded patients who had not been followed up on for 90 days after enrollment, those with NIHSS \< 4 or ≥ 25 or who had rapidly resolving symptoms before imaging results, and 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).
We 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.
For safety measures and to avoid associated confounders, we 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.
We 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 considered pregnant and lactating patients or those with stroke due to venous thrombosis, those with wake-up stroke and stroke following cardiac arrest or profuse hypotension ineligible for our trial.
The investigators excluded patients who were regular users of drugs that affect clopidogrel metabolism, such as proton pump inhibitors, statins, ketoconazole, dihydropyridine calcium channel blockers, and rifampin.
-
The ticagrelor arm will receive (180 mg loading dose during the first 12 hours of stroke onset, followed by 90 mg b.i.d from the 2nd to the 90th day)
Drug: Ticagrelor 90 MG Oral Tablet
The clopidogrel arm will receive (a 300 mg loading dose during the first 12 hours of stroke onset, followed by 75 mg once daily from the 2nd day to the 90th day).
Drug: Clopidogrel tablet
Efficacy and safety of 180 mg loading dose of ticagrelor administered within 24 hours of first-ever ischemic stroke followed by 90 mg bid 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 300 mg clopidogrel followed by 75 mg once 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
-the rate of new stroke in each group
Assessed during the follow-up period through telephone calls twice per week, a face-to-face interview, and suitable brain imaging in the outpatient clinic once per month and continued for three months
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
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. 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: 7 days
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.
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 favorable stroke outcome is considered with mRS value equals two or less.
Time frame: 90 days
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: 90 days
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: Undecided — 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 May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Kafrelsheikh University