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Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease

NCT06541691 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2025-03-19

No results posted yet for this study

Summary

Although both enteric-coated and plain formulations of aspirin are being used commonly, there are no high-quality comparisons between these formulations with respect to clinical efficacy outcomes in patients with atherosclerotic cardiovascular diseases (ASCVD). Air pollution is also a major contributor to the excess risk of cardiovascular events in many regions of the world. However, little is known about the effect of individual-level mitigation strategies against air pollution in reducing cardiovascular outcomes. The purpose of the first randomization is to compare the efficacy and safety of enteric-coated versus plain low-dose (81 mg) aspirin formulations in a double-blind fashion. The second randomization compares a multifaceted intervention including one-page educational flashcard, cell phone text messages alerting participants on polluted days, recommending them to stay indoors or wear KN-95 facemasks provided by the study team in case of necessary outdoor activity, and recommendation to consume citrus fruits on polluted days versus usual care. Both randomization are powered for clinical outcomes and the results will inform practice.

Conditions

Interventions

DRUG

Enteric-coated aspirin

Enteric-coated aspirin tablet 81 mg, once daily

DRUG

Plain aspirin

Plain aspirin tablet 81 mg, once daily

OTHER

Hybrid strategy

A hybrid strategy composed from: * A one-page educational flashcard * Alerting patients on highly polluted days via text message * Encouraging patients to stay at home or minimizing outdoor activity on highly polluted days * Encouraging patients via text message to wear KN-95 facemasks (provided by the investigators of this study) during outdoors time on highly polluted days * Encouraging patients to consume citrus fruits during highly polluted days

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Rajaie Cardiovascular Medical and Research Center

    lead OTHER

Principal Investigators

  • Parham Sadeghipour, M.D · Rajaie Cardiovascular Medical and Research Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-06
Primary Completion
2026-03-30
Completion
2027-03-30

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06541691 on ClinicalTrials.gov