Aspirin ved subklinisk koronararteriesykdom: En pilotstudie med randomisert kontrollert forsøk (ASCAD-P)
Aspirin ved subklinisk koronarsykdom: En pilotstudie med randomisert kontrollert design
In patients with subclinical coronary artery disease, the ASCAD-P study aims to assess the feasibility of a larger phase 3 pragmatic randomized controlled trial comparing prescription versus no prescription of low-dose aspirin in routine clinical practice.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Cardiovascular disease remains the leading cause of mortality worldwide. Recent large randomized trials have demonstrated limited net clinical benefit of aspirin in unselected primary prevention populations, leading to guideline recommendations against its systematic routine use for cardiovascular protection.
Patients with subclinical coronary artery disease represent a high-risk subgroup. These individuals have documented coronary artery disease but have not experienced overt cardiovascular events or undergone revascularization. Observational data suggest that this population carries a substantially increased risk of myocardial infarction compared with individuals without coronary atherosclerosis. However, the benefit-risk balance of aspirin in this intermediate-risk group remains uncertain
Primary Objective:
To evaluate the recruitment rate of a pilot randomized trial comparing low-dose aspirin prescription versus no prescription.
Secondary Objectives
To evaluate key feasibility metrics, including:
- The proportion of eligible patients who are randomized;
- Adherence and persistence to the assigned intervention at 12 months;
- The proportion of patients who do not complete the 12-month follow-up;
- Barriers to recruitment, adherence, and retention.
Exploratory Objectives:
To explore clinical outcomes at 12 months, including:
- The incidence of clinically significant bleeding events (BARC type 2, 3, or 5) and bleeding site;
- The incidence of major adverse cardiovascular events (MACE), defined as a composite of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization;
- Individual components of the composite endpoint;
- Cardiovascular mortality;
- Adverse Events and Serious Adverse Events.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Cyril Gagnon, MD
- Telefonnummer: 2698 514-376-3330
- E-post: cyril.gagnon@umontreal.ca
Studer Kontakt Backup
- Navn: Samara Bloom, MSc
- Telefonnummer: 2698 514-376-3330
- E-post: samara.bloom@icm-mhi.org
Studiesteder
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 1C8
- Rekruttering
- Montreal Heart Institute
-
Hovedetterforsker:
- Guillaume Marquis-Gravel, MD, MSc
-
Ta kontakt med:
- Cyril Gagnon, MD
- Telefonnummer: 2698 514-376-3330
- E-post: cyril.gagnon@umontreal.ca
-
Ta kontakt med:
- Samara Bloom, MSc
- Telefonnummer: 2698 514-376-3330
- E-post: samara.bloom@icm-mhi.org
-
Hovedetterforsker:
- Pierre Elias, MD
-
Hovedetterforsker:
- Cyril Gagnon, MD
-
Hovedetterforsker:
- Alino Demean Loghin, MD
-
Québec, Quebec, Canada, G1V 4G5
- Har ikke rekruttert ennå
- Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
-
Hovedetterforsker:
- Tomas Cieza, MD
-
Ta kontakt med:
- Roubie Dib
- Telefonnummer: (418) 656-8711
- E-post: roubie.dib.1@ulaval.ca
-
Ta kontakt med:
- Sarah Desjardins
- Telefonnummer: (418) 656-8711
- E-post: sarah.desjardins.2@ulaval.ca
-
Hovedetterforsker:
- Roubie Dib, MD
-
Hovedetterforsker:
- Sarah Desjardins, MD
-
Trois-Rivières, Quebec, Canada, G8Z 3R9
- Har ikke rekruttert ennå
- Centre hospitalier affilié universitaire régional (CHAUR)
-
Hovedetterforsker:
- Vincent Spagnoli, MD
-
Ta kontakt med:
- Farzin Brian Haghighat
- Telefonnummer: (819) 697-3333
- E-post: farzin.brian.haghighat@umontreal.ca
-
Hovedetterforsker:
- Farzin Brian Haghighat
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-
Documented coronary atherosclerosis, as defined by one of the following criteria:
- Coronary artery calcium (CAC) score > 0;
- Cardiac CT angiography (CCTA) / CoroScan: lesions <70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and <50% in the left main coronary artery;
- Coronary angiography: lesions <70% in the right coronary (RCA), left anterior descending (LAD), and circumflex (Cx) arteries or their branches, and <50% in the left main coronary artery; if performed, physiological coronary assessments (FFR, dPR, iFR, etc.) and intracoronary imaging (IVUS or OCT) must be negative for significant disease.
-
Willing and able to provide informed consent and comply with study procedures
Exclusion Criteria:
- History of myocardial infarction (MI), coronary revascularization, stroke, transient ischemic attack (TIA), or peripheral arterial revascularization procedure;
- Current prescription or clear indication for aspirin, low-molecular-weight heparin (LMWH), direct oral anticoagulants, or any other antithrombotic medication;
- Clear contraindication to aspirin;
- History of significant bleeding within the past year;
- Severe illness with limited life expectancy (i.e., <5 years);
- Any condition that, in the investigator's judgment, would make participation unsafe for the patient.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Low-dose Aspirin Prescription
Aspirin 81 mg orally once daily prescription |
Aspirin 81 mg orally once daily |
|
Annen: No Prescription
No prescription of aspirin 81 mg orally once daily |
No prescription of aspirin 81 mg orally once daily |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Monthly Recruitment Rate
Tidsramme: 12 months following study enrollment initiation
|
Average monthly patient recruitment rate: 0 ≤ Mean rate (patients/month) < 2 = study not feasible; 2 ≤ Mean rate (patients/month) < 4 = study feasible with protocol modifications; ≥ 4 Mean rate (patients/month) = study feasible without major protocol modifications. |
12 months following study enrollment initiation
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Hindringer for rekruttering, overholdelse og pasientbeholdelse
Tidsramme: Fra rekruttering til oppfølgingens slutt (12 måneder)
|
Fra rekruttering til oppfølgingens slutt (12 måneder)
|
|
|
Proportion of Eligible Patients Randomized
Tidsramme: 12 months following study enrollment initiation
|
Proportion of eligible patients who are randomized: 0% ≤ Proportion < 30% = study not feasible, major protocol modifications required; 30% ≤ Proportion < 61% = study feasible with protocol modifications; ≥ 61% = study feasible without protocol modifications. |
12 months following study enrollment initiation
|
|
Intervention Adherence
Tidsramme: From randomization to the end of follow-up (12 months)
|
Proportion of days on which patients take the assigned intervention (adherence): 0% ≤ Mean proportion < 25% = study not feasible, major protocol modifications required; 25% ≤ Mean proportion < 74% = study feasible with protocol modifications; ≥ 74% = study feasible without protocol modifications. |
From randomization to the end of follow-up (12 months)
|
|
Intervention Persistence
Tidsramme: From randomization to end of follow-up (12 months)
|
Proportion of patients who still take the assigned intervention at 12 months of follow-up (persistence): 0% ≤ Proportion < 25% = study not feasible, major protocol modifications required; 25% ≤ Proportion < 70% = study feasible with protocol modifications; ≥ 70% = study feasible without protocol modifications. |
From randomization to end of follow-up (12 months)
|
|
Proportion of Patients Lost to Follow-up
Tidsramme: End of follow-up (12 months)
|
Proportion of patients who do not complete the 12-month follow-up visit: ≥ 10% = study not feasible, major protocol modifications required; 6% ≤ Proportion < 10% = study feasible with protocol modifications; 0% ≤ Proportion < 6% = study feasible without protocol modifications. |
End of follow-up (12 months)
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Blødningsrate (BARC 2, 3, 5)
Tidsramme: Fra påmelding til slutten av oppfølgingen (12 måneder)
|
Fra påmelding til slutten av oppfølgingen (12 måneder)
|
|
|
Bivirkningsrate (AE) og alvorlig bivirkningsrate (SAE)
Tidsramme: Fra inkludering til slutten av oppfølgingen (12 måneder)
|
Fra inkludering til slutten av oppfølgingen (12 måneder)
|
|
|
Major Adverse Cardiovascular Event (MACE) Rate
Tidsramme: From enrollment to the end of follow-up (12 months)
|
MACE rate (all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization) at 12 months of follow-up |
From enrollment to the end of follow-up (12 months)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-3694
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