Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358313
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-04-05
Brief Title:
Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA
Sponsor:
Kafrelsheikh University
Organization:
Kafrelsheikh University
Study Overview
Official Title:
Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Minor Stroke or TIA a Randomized Controlled Single-blinded Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Along with the current clinical trial the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever minor stroke or TIA patients treated with clopidogrel and aspirin assessed through NIHSS mRS and possible adverse effects
Detailed Description:
The investigators will conduct a randomized controlled trial between April 2024 and April 2025 after the ethics committee of the faculty of medicine at Kafr el-Sheik University approves
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 atorvastatin arm which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months All the patients in the two groups received open-label aspirin at a loading dose of 75 to 300 mg and then 75 mg daily till the end of the 3 months and open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months
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 TOE in indicated patients ECG Monitoring daily ECG monitoring will be performed in indicated patients - 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
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 the 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 acute liver injury assessed by ALT AST test at 90 days statin-induced myopathy assessed by CPK at 90 days and other 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 atorvastatin arm which consisted of 300 patients who received 40 mg daily atorvastatin for 3 months and the rosuvastatin arm consisted of 300 patients who received 20 mg rosuvastatin daily for 3 months All the patients in the two groups received open-label aspirin at a loading dose of 75 to 300 mg and then 75 mg daily till the end of the 3 months and open-label clopidogrel at a loading dose of 300 mg and then 75 mg daily till the end of the 3 months
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 TOE in indicated patients ECG Monitoring daily ECG monitoring will be performed in indicated patients - 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
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 the 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 acute liver injury assessed by ALT AST test at 90 days statin-induced myopathy assessed by CPK at 90 days and other adverse effects assessed by a follow-up questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None