Key result
RCT compares enteric-coated versus plain aspirin for Thromboxane B2 inhibition in newly diagnosed ischemic stroke.
Why the study?
Uncertainty remains regarding whether enteric-coated aspirin blunts aspirin response and impacts cardiovascular risk reduction, prompting validation of its effect on thromboxane levels.
Does enteric-coated aspirin increase the incidence of aspirin non-responders compared to plain aspirin in patients with newly diagnosed ischemic stroke?
RCT
Open-label
consecutive randomized
No
Does enteric-coated aspirin increase the incidence of aspirin non-responders compared to plain aspirin in patients with newly diagnosed ischemic stroke?
Answers are grounded in this paper and cite their sources.
This study protocol outlines a trial to determine if enteric-coated aspirin blunts thromboxane B2 inhibition compared to plain aspirin in patients with newly diagnosed ischemic stroke.
INTRODUCTION: Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the reduction of cardiovascular risk. We hypothesize that EC formulation based on a previous report may blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic patients. Thus, it was imperative to ascertain and validate the effect of the EC formulation of Aspirin on the Thromboxane B2 (TXB2) level. METHODS/DESIGN: An open-label consecutive randomized interventional controlled trial. Patients with newly diagnosed ischemic stroke who are just about to start Aspirin were assessed for eligibility and inclusion in our trial. Consecutive patients (admitted to the stroke unit of Hamad General Hospital, Hamad Medical Corporation, Doha, Qatar) will be randomized to receive either EC aspirin or plain Aspirin. They will be required to continue taking them throughout the study (3 days). Demographics and laboratory records of the study participants will be abstracted from online records. Further study variables will be obtained manually in designated case record forms (CRF). The primary outcomes are the incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). Whereas secondary outcomes are the incidence of GIT bleeding of various preparations of Aspirin. The study was approved by MRC and IRB of Hamad Medical Corporation (MRC number: 01-18-156). DISCUSSION: This trial will determine potential differences in the efficacy of EC Aspirin and plain Aspirin on the Thromboxane B2 level. Additionally, it will ascertain the tolerability and safety of both formulations of Aspirin in patients with newly diagnosed ischemic stroke. These results will either support the current notion of no difference between the two formulations. However, if a difference is found, this will invite for future trials exploring clinical outcomes occurrence between various formulations. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT04330872 registered on April 2, 2020.
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Elshafei et al. (2020) conducted an RCT in newly diagnosed ischemic stroke. Enteric-coated (EC) aspirin vs. Plain Aspirin was evaluated on Incidence of aspirin non-responders (level of residual serum TXB2 associated with elevated thrombotic risk (<99.0% inhibition or TXB2 >3.1 ng/mL) within 72 h after three daily aspirin doses). This randomized controlled trial is designed to evaluate the effect of enteric-coated versus plain aspirin on Thromboxane B2 levels in patients with newly diagnosed ischemic stroke.
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