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

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Phase 4
Locations
Qatar
Study Type
Interventional
Intervention
Enteric Coated Aspirin Tablet
Plain Aspirin
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Newly diagnosed ischemic stroke who are just about to start aspirin.
  2. 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:

  1. Concomitant antiplatelet therapy (irrespective of the duration of the treatment).
  2. Patients on any prostaglandins related medications (non-steroidal anti-inflammatory drugs, misoprostol, and other ant secretory drugs among others).
  3. Any salicylate-containing supplements.
  4. Patients on the NG tube will be excluded from the study

Sites / Locations

  • Hamad Medical Corporation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Enteric coated Aspirin

Plain Aspirin

Arm Description

EC aspirin loading dose 300mg followed by 100 mg (2 days). The study's total duration is 3 days.

Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days) The study's total duration is 3 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.
Major and minor GIT bleeding

Full Information

First Posted
March 23, 2020
Last Updated
March 30, 2020
Sponsor
Hamad Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04330872
Brief Title
An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke.
Acronym
ECASIS
Official Title
An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke. Non-randomized Interventional Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
January 4, 2020 (Actual)
Study Completion Date
March 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enteric coated Aspirin
Arm Type
Active Comparator
Arm Description
EC aspirin loading dose 300mg followed by 100 mg (2 days). The study's total duration is 3 days.
Arm Title
Plain Aspirin
Arm Type
Placebo Comparator
Arm Description
Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days) The study's total duration is 3 days.
Intervention Type
Drug
Intervention Name(s)
Enteric Coated Aspirin Tablet
Intervention Description
Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days).
Intervention Type
Drug
Intervention Name(s)
Plain Aspirin
Intervention Description
Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).
Primary Outcome Measure Information:
Title
Incidence of Aspirin non-responders.
Description
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
Time Frame
At "Day 3"
Secondary Outcome Measure Information:
Title
Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.
Description
Major and minor GIT bleeding
Time Frame
After three daily aspirin doses ( at "Day 3")

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar

12. IPD Sharing Statement

Citations:
PubMed Identifier
36121499
Citation
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.
Results Reference
derived
PubMed Identifier
32443379
Citation
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.
Results Reference
derived

Learn more about this trial

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

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