Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA

Phase 3RecruitingNCT06591351

Kafrelsheikh University870 enrolled

Overview

Along with the current clinical trial, the efficacy and safety of a 300 mg loading dose of clopidogrel and 300 mg loading aspirin administered within 24 hours of the first-ever large-vessel minor stroke or TIA compared to 200 mg cilostazol and 300 mg loading aspirin were assessed through NIHSS, mRS, and possible adverse effects

The investigators conducted a single-blinded randomized controlled trial after the ethics committee of the faculty of medicine at Kafr el-Sheik University approved it. 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), both groups received 300 mg loading aspirin and 75 mg daily dose of aspirin. 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. • 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 a 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 adverse effects assessed by a follow-up questionnaire

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

870

Conditions

Ischemic Stroke

Interventions

Cilostazol 100 MGDRUG

Efficacy and safety of 200 mg cilostazol followed by 100 mg twice daily for three months and loading 300 mg aspirin and 75 mg aspirin maintenance will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects,

ClopidogrelDRUG

Efficacy and safety of 300 mg clopidogrel followed by 75mg once daily for three months and loading 300 mg aspirin and 75 mg aspirin maintenance will be assessed through NIHSS, mRS, duration of hospital stay, new ischemic stroke, and possible adverse effects,

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with large-vessel minor ischemic stroke or TIA who received antiplatelet treatment within the first 24 hours of the onset of ischemic stroke. Patients are not eligible for rt-PA treatment Exclusion Criteria: * The investigators excluded patients who had not been followed up on for 90 days after enrollment, those with NIHSS \< 5 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). 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

Locations (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

RECRUITING

Outcomes

Primary Outcomes

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 a 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

Secondary Outcomes

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

Central Contacts

mohamed G. Zeinhom, MD

CONTACT

2001009606828 mohamed_gomaa@med.kfs.edu.eg

sherihan R. ahmed, MD

CONTACT

2001113432342 sherihan_rezq@med.kfs.edu.eg

Data from ClinicalTrials.gov

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