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Completed

NCT Number: NCT04330872

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

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamad Medical Corporation

Doha, 3050, Qatar

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enteric Coated Aspirin Tablet

Drug

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

Drug

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

Primary outcomes

  1. Incidence of Aspirin non-responders.

    Time frame: 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 outcomes

  1. Incidence of Gastrointestinal bleeding consequent upon aspirin therapy.

    Time frame: After three daily aspirin doses ( at "Day 3")

    Major and minor GIT bleeding

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Acronym: ECASIS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2020
Registry last updated
Apr 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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