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

ConditionsAcute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)Dual Anti-platelet Therapy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorAssiut University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • Aspirin-Free Strategy

    Drug

    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

  • Dual Antiplatelet Therapy

    Drug

    Participants will continue standard antiplatelet therapy according to current clinical practice after complete coronary revascularization.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Aspirin + clopidogrelExperimental treatment 1 intervention
Group B: Standered Antiplatelet Therapy (Aspirin + Clopidogrel)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Net adverse clinical events

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).

Time frame
12 months

Secondary outcomes

1

Major Adverse Cardiovascular Events (MACE)

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

Time frame
12 months
2

Bleeding

The primary safety outcome is the occurrence of bleeding complications, which will be characterized using the international Bleeding Academic Research Consortium (BARC) consensus

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: