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

Phase 4

Completed

• Conditions: Stroke, Ischemic
• Interventions: Drug: Enteric Coated Aspirin Tablet; Drug: Plain Aspirin

• Registration Number: NCT04330872
• Lead Sponsor: Hamad Medical Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-26
• Primary Completion: 2020-01-04
• Status Verified: 2020-03
• Study Completion: 2020-03-04
• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-30
• Last Update Submitted: 2020-03-30
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enteric coated Aspirin	Enteric Coated Aspirin Tablet	EC aspirin loading dose 300mg followed by 100 mg (2 days). The study's total duration is 3 days.
Plain Aspirin	Plain Aspirin	Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days) The study's total duration is 3 days.

Primary Outcome Measures

Name	Time	Method
Incidence of Aspirin non-responders.	At "Day 3"	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

Name	Time	Method
Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.	After three daily aspirin doses ( at "Day 3")	Major and minor GIT bleeding

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar