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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2020-03-04

Brief Summary

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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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Detailed Description

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Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enteric coated Aspirin

EC aspirin loading dose 300mg followed by 100 mg (2 days).

The study's total duration is 3 days.

Group Type ACTIVE_COMPARATOR

Enteric Coated Aspirin Tablet

Intervention Type 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

Dispersible Aspirin loading dose 300mg followed by 75mg tablets (2 days)

The study's total duration is 3 days.

Group Type PLACEBO_COMPARATOR

Plain Aspirin

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No