Early reduction of antiplatelet therapy in patients with Acute Coronary Syndrome treated with stent implantation and at high risk of bleeding.
Key facts
- Where
- Catania, Cotignola, Genoa, Messina, Milan, Rivoli és Turin, OlaszországSee the 7 sites
- Phase
- 3. fázis
Where in Olaszország
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, OlaszországTaking people
- Gvm Hospitals Of Care And ResearchCotignola, OlaszországTaking people
- IRCCS Ospedale Policlinico San MartinoGenoa, OlaszországTaking people
- Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessina, OlaszországTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, OlaszországTaking people
- Azienda Sanitaria Locale TO3Rivoli, OlaszországTaking people
- Azienda Ospedaliera Ordine Mauriziano di TorinoTurin, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliera Universitaria Gaetano Martino Messina
- Trial code
- EU 2023-509868-20-00
- Record updated
- 2024. május 14.
- Original description
The primary objective is to evaluate the pharmacodynamic effect of 3 different regimens of P2Y12 inhibitor de-escalation (prasugrel 5mg, ticagrelor 60mg/bid or clopidogrel 75mg) versus full-dose potent P2Y12 inhibitor (prasugrel 10mg or ticagrelor 90mg bid) on platelet reactivity, and to evaluate which treatment achieves the highest proportion of patients in the optimal platelet reactivity (OPR) at treatment steady-state.Read full original descriptionShow less
De-Escalation of Antiplatelet Therapy to Evaluate Platelet Reactivity and Clinical Outcomes after Coronary Stenting in Patients at High Bleeding Risk and Recent Acute Coronary Syndrome: DESC-HBR trial
The primary objective is to evaluate the pharmacodynamic effect of 3 different regimens of P2Y12 inhibitor de-escalation (prasugrel 5mg, ticagrelor 60mg/bid or clopidogrel 75mg) versus full-dose potent P2Y12 inhibitor (prasugrel 10mg or ticagrelor 90mg bid) on platelet reactivity, and to evaluate which treatment achieves the highest proportion of patients in the optimal platelet reactivity (OPR) at treatment steady-state.
Inclusion: 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: 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; Age < 18 years.