NCT06591299 Combining Aspirin With Cilostazol or Clopidogrel in Minor Stroke or TIA
| NCT ID | NCT06591299 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Kafrelsheikh University |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 870 participants |
| Start Date | 2022-04-15 |
| Primary Completion | 2024-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 870 participants in total. It began in 2022-04-15 with a primary completion date of 2024-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 minor stroke or TIA compared to 200 mg cilostazol were assessed through NIHSS, mRS, and possible adverse effects
Eligibility Criteria
Inclusion Criteria: * the investigators included both genders with eligible ages ranging between 18-75 years, with the first-ever presentation with 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.
Contact & Investigator
mohamed G. Zeinhom, MD
PRINCIPAL INVESTIGATOR
neurology department kafr el-sheikh university
Frequently Asked Questions
Who can join the NCT06591299 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06591299 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 870 participants.
Is NCT06591299 currently recruiting?
Yes, NCT06591299 is actively recruiting participants. Contact the research team at mohamed_gomaa@med.kfs.edu.eg for enrollment information.
Where is the NCT06591299 trial being conducted?
This trial is being conducted at Kafr ash Shaykh, Egypt.
Who is sponsoring the NCT06591299 clinical trial?
NCT06591299 is sponsored by Kafrelsheikh University. The principal investigator is mohamed G. Zeinhom, MD at neurology department kafr el-sheikh university. The trial plans to enroll 870 participants.
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