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

Hamad Medical Corporation (HMC)

Status and phase: Completed; Phase 4

Conditions: Stroke, Ischemic

Treatments: Drug: Plain Aspirin; Drug: Enteric Coated Aspirin Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04330872

01-18-156

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups, including a placebo group

Enteric coated Aspirin

Active Comparator group

Description:

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

Treatment:

Drug: Enteric Coated Aspirin Tablet

Plain Aspirin

Placebo Comparator group

Description:

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

Treatment:

Drug: Plain Aspirin