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

NCT07736196 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: Aspirin-free strategy2542
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dual Anti-platelet Therapy; Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Outcome Measures

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).

  12 months

Secondary Outcomes (2)

• Major Adverse Cardiovascular Events (MACE)

  12 months

• Bleeding

  12 months

Study Arms (2)

Aspirin + clopidogrel

EXPERIMENTAL

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.

Drug: Aspirin-Free Strategy

Standered Antiplatelet Therapy (Aspirin + Clopidogrel)

ACTIVE COMPARATOR

Participants will continue standard antiplatelet therapy according to current guideline-directed management after complete coronary revascularization.

Drug: Dual Antiplatelet Therapy

Interventions

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

Aspirin + clopidogrel

Dual Antiplatelet Therapy DRUG

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

Standered Antiplatelet Therapy (Aspirin + Clopidogrel)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Must have an established, objectively confirmed diagnosis of an acute coronary syndrome, classified as STEMI, NSTEMI, or high-risk Unstable Angina.
• \. Underwent successful PCI with deployment of contemporary drug-eluting stents (DES) and TIMI 3 flow.
• \. Achieved documented complete revascularization of all angiographically significant lesions during the index procedure.
• \. 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.
• \. 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.

You may not qualify if:

• 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.
• \. Any prior historical or documented acute, subacute, or late definitive stent thrombosis.
• \. 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).
• \. Definitive clinical indication for continuous, long-term oral anticoagulation therapy (e.g., atrial fibrillation, mechanical valves, deep vein thrombosis, or pulmonary embolism).
• \. Active major pathological bleeding, history of any spontaneous or traumatic intracranial hemorrhage, vascular malformations of the central nervous system, or an established bleeding diathesis.
• \. 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.
• \. Known severe hypersensitivity, documented allergy, or major medical intolerance to acetylsalicylic acid (Aspirin) or clopidogrel (Plavix).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Asyut Governorate, 71515, Egypt

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Asmaa Sayed Shaban, MBBch

CONTACT

+2013840163; asmaasayed641@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking (open-label). Participants and investigators will be aware of the assigned treatment. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor

Model Details: Participants with acute coronary syndrome who have undergone complete revascularization will be randomly assigned in a 1:1 ratio to either an aspirin-free strategy (discontinuation of aspirin after 3-6 months of dual antiplatelet therapy with continuation of P2Y12 inhibitor monotherapy) or continued standard antiplatelet therapy. Participants will be followed for ischemic and bleeding outcomes.

Study Record Dates

• First Submitted: July 25, 2026
• First Posted: July 30, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): June 1, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)