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2023-509868-20-00RecruitingPhase 3

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

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 May 2024 · Not updated for over 12 months - ask the site whether it is still open

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Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
200 (estimated)
First submitted
16 Mar 2024
Start date
24 Jun 2023
Lead sponsor
Azienda Ospedaliera Universitaria Gaetano Martino Messina
EU CT number
2023-509868-20-00
EudraCT number
2023-000029-10

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 200
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

  • Age < 18 years

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (7)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCataniaItalyRecruiting
Gvm Hospitals Of Care And ResearchCotignolaItalyRecruiting
IRCCS Ospedale Policlinico San MartinoGenoaItalyRecruiting
Azienda Ospedaliera Universitaria Gaetano Martino MessinaMessinaItalyRecruiting
ASST Grande Ospedale Metropolitano NiguardaMilanItalyRecruiting
Azienda Sanitaria Locale TO3RivoliItalyRecruiting
Azienda Ospedaliera Ordine Mauriziano di TorinoTurinItalyRecruiting

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