Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591351
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combining Aspirin With Cilostazol or Clopidogrel in Large-vessel Minor Stroke or TIA a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 hisher 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
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 hisher 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None