Cargando…
An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS)
INTRODUCTION: Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic pati...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254488/ https://www.ncbi.nlm.nih.gov/pubmed/32443379 http://dx.doi.org/10.1097/MD.0000000000020307 |
_version_ | 1783539550382981120 |
---|---|
author | Elshafei, Mohamed Nabil Imam, Yahia Mohamed, Mouhand F.H. AlSaud, Arwa Ebrahim Ahmed, Mohamed Sayed Obeidat, Khaldun Saeid, Razan Ali, Mohamed Abdallah, Ibtihal M. Parray, Aeijaz Sultan Danjuma, Mohammed Ibn-Masoud |
author_facet | Elshafei, Mohamed Nabil Imam, Yahia Mohamed, Mouhand F.H. AlSaud, Arwa Ebrahim Ahmed, Mohamed Sayed Obeidat, Khaldun Saeid, Razan Ali, Mohamed Abdallah, Ibtihal M. Parray, Aeijaz Sultan Danjuma, Mohammed Ibn-Masoud |
author_sort | Elshafei, Mohamed Nabil |
collection | PubMed |
description | INTRODUCTION: Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level. METHODS/DESIGN: An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156). DISCUSSION: This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT04330872 registered on April 2, 2020 |
format | Online Article Text |
id | pubmed-7254488 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-72544882020-06-15 An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) Elshafei, Mohamed Nabil Imam, Yahia Mohamed, Mouhand F.H. AlSaud, Arwa Ebrahim Ahmed, Mohamed Sayed Obeidat, Khaldun Saeid, Razan Ali, Mohamed Abdallah, Ibtihal M. Parray, Aeijaz Sultan Danjuma, Mohammed Ibn-Masoud Medicine (Baltimore) 3400 INTRODUCTION: Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level. METHODS/DESIGN: An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156). DISCUSSION: This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT04330872 registered on April 2, 2020 Wolters Kluwer Health 2020-05-15 /pmc/articles/PMC7254488/ /pubmed/32443379 http://dx.doi.org/10.1097/MD.0000000000020307 Text en Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0 |
spellingShingle | 3400 Elshafei, Mohamed Nabil Imam, Yahia Mohamed, Mouhand F.H. AlSaud, Arwa Ebrahim Ahmed, Mohamed Sayed Obeidat, Khaldun Saeid, Razan Ali, Mohamed Abdallah, Ibtihal M. Parray, Aeijaz Sultan Danjuma, Mohammed Ibn-Masoud An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) |
title | An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) |
title_full | An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) |
title_fullStr | An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) |
title_full_unstemmed | An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) |
title_short | An investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ECASIS) |
title_sort | investigation into the impact of enteric coated of aspirin in patients with newly diagnosed ischemic stroke (ecasis) |
topic | 3400 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7254488/ https://www.ncbi.nlm.nih.gov/pubmed/32443379 http://dx.doi.org/10.1097/MD.0000000000020307 |
work_keys_str_mv | AT elshafeimohamednabil aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT imamyahia aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT mohamedmouhandfh aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT alsaudarwaebrahim aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT ahmedmohamedsayed aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT obeidatkhaldun aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT saeidrazan aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT alimohamed aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT abdallahibtihalm aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT parrayaeijazsultan aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT danjumamohammedibnmasoud aninvestigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT elshafeimohamednabil investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT imamyahia investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT mohamedmouhandfh investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT alsaudarwaebrahim investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT ahmedmohamedsayed investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT obeidatkhaldun investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT saeidrazan investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT alimohamed investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT abdallahibtihalm investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT parrayaeijazsultan investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis AT danjumamohammedibnmasoud investigationintotheimpactofentericcoatedofaspirininpatientswithnewlydiagnosedischemicstrokeecasis |