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

Stroke, Ischemic Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330872
• Other study ID #: 01-18-156
• Status: Completed
• Phase: Phase 4
• Start date: August 26, 2019
• Est. completion date: March 4, 2020

Study information

• Verified date: March 2020
• Source: Hamad Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 4, 2020
• Est. primary completion date: January 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Enteric Coated Aspirin Tablet
Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days).
• Plain Aspirin
Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.	Major and minor GIT bleeding	After three daily aspirin doses ( at "Day 3")