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Aspirin-Free Strategy After 3-6 Month Dual Antiplatelet Therapy in Acute Coronary Syndrome

29 juli 2026 bijgewerkt door: Asmaa Sayed Shaban Ali, Assiut University

Aspirin-Free Strategy After 3-6 Month Dual Antiplatelet Therapy in Acute Coronary Syndrome Patients Who Underwent Complete Revascularization : A Randomized Controlled Trial

This randomized controlled trial aims to evaluate the safety and efficacy of an aspirin-free strategy after 3-6 months of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) who have undergone complete coronary revascularization by percutaneous coronary intervention (PCI). Participants will be randomized to either discontinue aspirin and continue P2Y12 inhibitor monotherapy or continue standard antiplatelet therapy. The primary objective is to determine whether the aspirin-free strategy reduces bleeding events without increasing ischemic events during follow-up.

Studie Overzicht

Gedetailleerde beschrijving

Acute Coronary Syndrome (ACS) remains a leading cause of cardiovascular mortality and morbidity worldwide. Current management of ACS-including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and high-risk unstable angina (UA)-relies on early invasive revascularization using Percutaneous Coronary Intervention (PCI) with contemporary Drug-Eluting Stents (DES). Following PCI, endothelial injury and stent implantation activate platelet aggregation and thrombosis, making Dual Antiplatelet Therapy (DAPT) with aspirin plus a P2Y12 inhibitor the standard treatment to prevent stent thrombosis and recurrent ischemic events. International guidelines have traditionally recommended 12 months of DAPT after ACS. However, prolonged DAPT increases the risk of bleeding, including gastrointestinal and intracranial hemorrhage, which is associated with higher mortality, treatment discontinuation, poor adherence, and increased healthcare utilization.

To improve the balance between ischemic protection and bleeding risk, several landmark randomized trials-including TWILIGHT, TICO, STOPDAPT-2, STOPDAPT-3, SMART-CHOICE, and GLOBAL LEADERS-have investigated abbreviated DAPT followed by P2Y12 inhibitor monotherapy after 1-3 months of treatment. These studies consistently demonstrated a significant reduction in major bleeding without a corresponding increase in major ischemic outcomes, including myocardial infarction or stent thrombosis.

Despite these promising findings, most available evidence has been generated in East Asian populations, where genetic factors, including CYP2C19 polymorphisms, and differences in thrombotic and bleeding risk may limit the generalizability of the results to other populations This clinical trial aims to address this important evidence gap by evaluating the safety and efficacy of abbreviated DAPT followed by P2Y12 inhibitor monotherapy in a non-Asian ACS population undergoing PCI with contemporary drug-eluting stents

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypte, 71515
        • Assiut University hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  • 1. Must have an established, objectively confirmed diagnosis of an acute coronary syndrome, classified as STEMI, NSTEMI, or high-risk Unstable Angina.

    2. Underwent successful PCI with deployment of contemporary drug-eluting stents (DES) and TIMI 3 flow.

    3. Achieved documented complete revascularization of all angiographically significant lesions during the index procedure.

    4. Maintained absolute adherence to standard, uncomplicated combination DAPT for exactly 30 ± 7 days following the index PCI, remaining completely free of any ischemic or bleeding events during this initial month.

    5. Patient is fully coherent, cooperative, able to comply with the mandated multi-month follow-up schedule, and has provided independent, written, personally signed informed consent prior to randomization.

Exclusion Criteria:

Left Main (LM) Coronary Artery Disease & bifurcation lesions with 2 stents : Any angiographically documented significant stenosis (>50% diameter stenosis) involving the unprotected left main coronary artery trunk, regardless of whether it was treated with a stent during the index procedure or left untreated.

2. Incomplete Revascularization / Residual Target Lesions: Presence of any remaining untreated coronary lesion with >50% diameter stenosis in any major epicardial vessel or branch with a reference vessel diameter ≥2.0 mm that requires, or is planned to require, any future surgical or percutaneous revascularization within the next 12 months. This 'other lesion' exclusion ensures a fully revascularized cohort.

3. Any prior historical or documented acute, subacute, or late definitive stent thrombosis.

4. High baseline ischemic features including end-stage chronic kidney disease (eGFR < 30 mL/min/1.73m²), severe left ventricular dysfunction (LVEF < 30%), or an un-revascularized multi-vessel burden with high residual SYNTAX score (>22).

5. Definitive clinical indication for continuous, long-term oral anticoagulation therapy (e.g., atrial fibrillation, mechanical valves, deep vein thrombosis, or pulmonary embolism).

6. Active major pathological bleeding, history of any spontaneous or traumatic intracranial hemorrhage, vascular malformations of the central nervous system, or an established bleeding diathesis.

7. Active system-wide infections, or documented chronic systemic inflammatory or autoimmune disorders (such as severe active rheumatoid arthritis, systemic lupus erythematosus, polymyalgia rheumatica, active inflammatory bowel disease), or active malignancies, which confound baseline leukocyte values.

8. Known severe hypersensitivity, documented allergy, or major medical intolerance to acetylsalicylic acid (Aspirin) or clopidogrel (Plavix).

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Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Aspirin + clopidogrel
Aspirin will be discontinued after 3-6 months of dual antiplatelet therapy. Participants will continue P2Y12 inhibitor monotherapy (Clopidogrel 75 mg once daily or Ticagrelor 90 mg twice daily, according to the treating physician) for the remainder of the follow-up.
Aspirin will be discontinued after 3-6 months of dual antiplatelet therapy, and participants will continue P2Y12 inhibitor monotherapy for the remainder of the study follow-up
Actieve vergelijker: Standered Antiplatelet Therapy (Aspirin + Clopidogrel)
Participants will continue standard antiplatelet therapy according to current guideline-directed management after complete coronary revascularization.
Participants will continue standard antiplatelet therapy according to current clinical practice after complete coronary revascularization.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Net adverse clinical events
Tijdsspanne: 12 months
Composite of major adverse cardiovascular events (cardiovascular death, myocardial infarction, ischemic stroke, or definite/probable stent thrombosis) and major bleeding (BARC type 3 or 5).
12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Major Adverse Cardiovascular Events (MACE)
Tijdsspanne: 12 months

Major Adverse Cardiac Events (MACE): A strict composite endpoint consisting of cardiovascular mortality, non-fatal myocardial infarction, or acute ischemic stroke.

  • Cardiovascular Mortality: Incorporates any death resulting from an acute myocardial infarction, sudden cardiac death, fatal cardiac arrest, cardiogenic shock, terminal heart failure, fatal stroke, or any death directly caused by a documented procedural complication related to the index or staged PCI.
  • Myocardial Infarction (MI): Diagnosed and classified in strict accordance with the Fourth Universal Definition of Myocardial Infarction (Type 1 spontaneous, Type 2 demand mismatch, Type 4a PCI-related).
  • Stent Thrombosis (ST): Formally categorized according to the Academic Research Consortium (ARC) consensus definitions into definite, probable, or possible stent thrombosis. Definite Stent Thrombosis requires unequivocal angiographic confirmation of a thrombus originating within or directly adjacent to the stented segment
12 months
Bleeding
Tijdsspanne: 12 months
The primary safety outcome is the occurrence of bleeding complications, which will be characterized using the international Bleeding Academic Research Consortium (BARC) consensus
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

15 juli 2026

Primaire voltooiing (Geschat)

30 juli 2029

Studie voltooiing (Geschat)

1 juni 2030

Studieregistratiedata

Eerst ingediend

25 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

29 juli 2026

Eerst geplaatst (Werkelijk)

30 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • Aspirin-free strategy2542

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

There is no plan to share individual participant data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

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