Early reduction of antiplatelet therapy in patients with Acute Coronary Syndrome treated with stent implantation and at high risk of bleeding.

Phase 1

• Conditions: Acute coronary syndrome; MedDRA version: 20.0Level: PTClassification code: 10051592Term: Acute coronary syndrome Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-509868-20-00
• Lead Sponsor: Azienda Ospedaliera Universitaria Gaetano Martino Messina

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Informed Consent signed and dated., -Patients deemed at HBR according to standard definitions (i.e. PRECISE-DAPT =25 or HBR-ARC with at least 1 major or 2 minor criteria), -Treated with PCI due to a recent ACS (i.e. unstable angina, non-ST segment elevated myocardial infarction or ST segment elevated myocardial infarction) 30 ±7 days earlier., -Treated with DAPT with full-dose potent P2Y12 inhibitors (e.g. prasugrel 10mg or ticagrelor 90mg bid) according to international guidelines recommendations

Exclusion Criteria

Age < 18 years, •Inability to follow the procedures of the study (language problems, mental disorders, dementia) or comorbidities associated with less than 12 months-life expectation (active malignancies drug or alcohol abuse, etc.) or other conditions that might result in protocol non­compliance., Known intolerance, hypersensitivity or contraindication (including active bleeding) to aspirin, clopidogrel, prasugrel, ticagrelor or to any of the excipients, Indication to oral anticoagulation, Indication to prolonged treatment with full-dose potent P2Y12 inhibitors (e.g. previous stent thrombosis, stenting of last remaining vessel, stent with indication for longer-term DAPT, perceived very high coronary ischemic risk etc.), Any planned major surgery or interventional procedure requiring treatment modification, Prior transient ischemic attack, ischemic or haemorrhagic stroke, Severe hepatic insufficiency (Child-Pugh class C), Ongoing therapy with strong CYP3A inducers or strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir etc.), •Women who are pregnant, breast feeding or of childbearing potential (i.e. fertile, following menarche and who are not surgically sterile, including hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or post-menopausal defined as no menses for 12 months without an alternative medical cause); Participation in another study with investigational drug within the 30 days, or 5 half-lives of the study drug whichever is longer, preceding and during the present study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified