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

An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke. Non-randomized Interventional Controlled Clinical Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04330872

Acronym

ECASIS

Enrollment

Registered

2020-04-02

Start date

2019-08-26

Completion date

2020-03-04

Last updated

2020-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

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.

Interventions

DRUGEnteric 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).

DRUGPlain Aspirin

Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Qatar

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026