Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541691
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-02
Brief Title:
Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Coated Or Chewable Aspirin in Patients With Established Atherosclerotic Disease and a Hybrid Strategy to Mitigate the Adverse Effects of Air Pollution The COATED-AIR Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COATED-AIR
Brief 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
Detailed Description:
- Background Aspirin is a key treatment option of patients with atherosclerotic cardiovascular disease ASCVD The enteric coating has emerged as a potential solution to minimize the exposure of the gastric mucosa to the medication However change in the medication main site of absorption might negatively impact the pharmacokineticspharmacodynamics of aspirin and alter its antithrombotic properties leading to diminished efficacy of the medication A sufficiently large randomized controlled trial with a long-term follow-up to compare the effectiveness of enteric-coated versus plain aspirin in reducing adverse cardiovascular events and mitigating the adverse effects of the medication in patients with ASCVD is lacking
Ambient air pollution is a prominent cause of mortality being associated with 67 million deaths worldwide every year half of which are attributable to cardiovascular causes Near the half of these deaths is attributable to cardiovascular causes Several patient-level interventions have been proposed to counteract with the adverse effects of the air pollution including alerting patients via text message staying at home using face masks or consuming citrus fruits as a source of vitamin C during the days with air pollution However the effect of implementing these strategies individually and especially as a group in mitigating the adverse effects of the air pollution has not yet been studied in a randomized controlled trial powered for clinical outcomes
The purpose of the current randomized clinical trial is to compare the efficacy and safety of enteric-coated versus plain low-dose 81 mg aspirin formulations in a double-blind fashion and an open-label comparison of a multifaceted intervention including a one-page informational flashcard cell phone message alerting on days with poor air quality to encourage patients not to spend time outdoors or to wear KN-95 facemasks outdoors in those days and encouraging patients to consume citrus fruits on highly polluted days hereafter referred to as hybrid strategy versus usual care in a multicenter randomized controlled trial RCT with a 2x2 factorial design
- Design and Randomization method Multicenter randomized controlled trial with a 2x2 full factorial design with double-blind randomization with a 11 allocation ratio to low-dose enteric-coated vs plain aspirin and open-label randomization with 11 allocation ratio to hybrid strategy to reduce the cardiovascular effects of air pollution vs usual care Permuted block randomization with block sizes of 8 12 and 16 chosen randomly via an electronic web-based system will be used for the study The allocation sequence will be concealed All outcomes will be adjudicated by a Clinical Events Committee blinded to the assigned treatments
- Setting Teaching hospitals in Tehran province Iran will be involved
- Statistical consideration and sample size calculation An event-driven approach was considered for the calculation of sample size Considering a relative hazard reduction of 23 in the first aspirin formulation randomization and 25 in the second air pollution mitigation strategy randomization to provide a two-sided alpha of 005 and a statistical power of 80 a total number of 460 primary efficacy outcomes for the first randomization and 380 primary efficacy outcomes for the second randomization would be needed An event-rate of 185 for the incidence of primary efficacy outcome in the control arm of the first randomization and 192 for the incidence of primary efficacy outcome in the control arm of the second randomization was assumed per a median follow-up of 2-year Ultimately Considering 4 dropout rate per each randomization a total number of 2920 and 2732 patients would be needed for the first and second randomizations respectively
Ambient air pollution is a prominent cause of mortality being associated with 67 million deaths worldwide every year half of which are attributable to cardiovascular causes Near the half of these deaths is attributable to cardiovascular causes Several patient-level interventions have been proposed to counteract with the adverse effects of the air pollution including alerting patients via text message staying at home using face masks or consuming citrus fruits as a source of vitamin C during the days with air pollution However the effect of implementing these strategies individually and especially as a group in mitigating the adverse effects of the air pollution has not yet been studied in a randomized controlled trial powered for clinical outcomes
The purpose of the current randomized clinical trial is to compare the efficacy and safety of enteric-coated versus plain low-dose 81 mg aspirin formulations in a double-blind fashion and an open-label comparison of a multifaceted intervention including a one-page informational flashcard cell phone message alerting on days with poor air quality to encourage patients not to spend time outdoors or to wear KN-95 facemasks outdoors in those days and encouraging patients to consume citrus fruits on highly polluted days hereafter referred to as hybrid strategy versus usual care in a multicenter randomized controlled trial RCT with a 2x2 factorial design
- Design and Randomization method Multicenter randomized controlled trial with a 2x2 full factorial design with double-blind randomization with a 11 allocation ratio to low-dose enteric-coated vs plain aspirin and open-label randomization with 11 allocation ratio to hybrid strategy to reduce the cardiovascular effects of air pollution vs usual care Permuted block randomization with block sizes of 8 12 and 16 chosen randomly via an electronic web-based system will be used for the study The allocation sequence will be concealed All outcomes will be adjudicated by a Clinical Events Committee blinded to the assigned treatments
- Setting Teaching hospitals in Tehran province Iran will be involved
- Statistical consideration and sample size calculation An event-driven approach was considered for the calculation of sample size Considering a relative hazard reduction of 23 in the first aspirin formulation randomization and 25 in the second air pollution mitigation strategy randomization to provide a two-sided alpha of 005 and a statistical power of 80 a total number of 460 primary efficacy outcomes for the first randomization and 380 primary efficacy outcomes for the second randomization would be needed An event-rate of 185 for the incidence of primary efficacy outcome in the control arm of the first randomization and 192 for the incidence of primary efficacy outcome in the control arm of the second randomization was assumed per a median follow-up of 2-year Ultimately Considering 4 dropout rate per each randomization a total number of 2920 and 2732 patients would be needed for the first and second randomizations respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None