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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enteric coated Aspirin | Active Comparator | EC aspirin loading dose 300mg followed by 100 mg (2 days). The study's total duration is 3 days. |
|
| Plain Aspirin | Placebo Comparator | Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days) The study's total duration is 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric Coated Aspirin Tablet | Drug | Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days). |
| 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" |
| 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") |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamad Medical Corporation | Doha | 3050 | Qatar |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36121499 | Derived | Elshafei MN, Imam Y, Alsaud AE, Chandra P, Parray A, Abdelmoneim MS, Obeidat K, Saeid R, Ali M, Ayadathil R, Mohamed MFH, Abdallah IM, Mohammed S, Akhtar N, Danjuma MI. The impact of enteric coating of aspirin on aspirin responsiveness in patients with suspected or newly diagnosed ischemic stroke: prospective cohort study: results from the (ECASIS) study. Eur J Clin Pharmacol. 2022 Nov;78(11):1801-1811. doi: 10.1007/s00228-022-03391-2. Epub 2022 Sep 19. | |
| 32443379 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Plain Aspirin | Drug | Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days). |
|
| Derived |
| Elshafei MN, Imam Y, Mohamed MFH, AlSaud AE, Ahmed MS, Obeidat K, Saeid R, Ali M, Abdallah IM, Parray AS, Danjuma MI. An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS). Medicine (Baltimore). 2020 May;99(20):e20307. doi: 10.1097/MD.0000000000020307. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |