An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke.

Study Overview
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Brief Summary
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Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of CV risk. We hypothesize that EC formulation based on the previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients.

Official Title
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An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke. Non-randomized Interventional Controlled Clinical Trial.

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Drug: Enteric Coated Aspirin Tablet
* Drug: Plain Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosed ischemic stroke who are just about to start aspirin. No prior history of cardiovascular morbidity (including ischemic heart disease, chronic kidney disease, peripheral vascular disease) 3-18- 75 years. 4-Patients with ischemic stroke who underwent reperfusion intervention (catheter-directed thrombolysis and/or thrombectomy) regardless of the time of presentation (i.e within or outside the therapeutic window as the managing stroke deem fit. Exclusion Criteria: Concomitant antiplatelet therapy (irrespective of the duration of the treatment). Patients on any prostaglandins related medications (non-steroidal anti-inflammatory drugs, misoprostol, and other ant secretory drugs among others). Any salicylate-containing supplements. Patients on the NG tube will be excluded from the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Enteric coated Aspirin<br>EC aspirin loading dose 300mg followed by 100 mg (2 days). The study's total duration is 3 days. | Drug: Enteric Coated Aspirin Tablet<br>* Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days).<br>|
| Placebo Comparator: Plain Aspirin<br>Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days) The study's total duration is 3 days. | Drug: Plain Aspirin<br>* Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Aspirin non-responders. | Aspirin nonresponsiveness is defined as a level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/ml) after 3 daily aspirin doses | At Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Gastrointestinal bleeding consequent upon aspirin therapy. | Major and minor GIT bleeding | After three daily aspirin doses ( at Day 3) |