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
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
- Diseases
- Coronary artery disease
- 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
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania | Catania | Italy | Recruiting |
| Gvm Hospitals Of Care And Research | Cotignola | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina | Messina | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Italy | Recruiting |
| Azienda Sanitaria Locale TO3 | Rivoli | Italy | Recruiting |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Turin | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.