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NCT07736196Not yet recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
300 (estimated)
First submitted
25 Jul 2026
Start date
15 Jul 2026
Primary completion date
30 Jul 2029
Lead sponsor
Assiut University
NCT number
NCT07736196

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 300
  • From 15 Jul 2026 to the primary completion date, 30 Jul 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

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

Lab values

  • 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).
  • 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.

Other

  • \-

Who the study is looking for

  • 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.

Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Assiut University hospital
Coordinator of this site? Confirm its status
AsyutEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.