Reducing Antiplatelet Therapy for Patients at High Risk of Bleeding After Heart Events
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
This study tests if giving a lower dose of a heart medication to patients at high risk of bleeding after a heart event can help them stay safe while still keeping their blood platelets working well.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Policlinico "G. Martino" Academic / other |
| Locations | 2 sites (Messina and 1 other locations) |
| Trial ID | NCT05903976 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effects of de-escalating P2Y12 inhibitor therapy in high bleeding risk patients who have recently experienced acute coronary syndrome. Participants will be assigned to receive either a lower potency or lower-dose P2Y12 inhibitor or continue with full-dose potent P2Y12 inhibitors. The primary goal is to assess the proportion of patients achieving optimal platelet reactivity, while secondary objectives include monitoring clinical events and quality of life. The study will utilize various pharmacodynamic assessments to measure platelet reactivity at multiple time points.
Who should consider this trial
Good fit: Ideal candidates are adults at high bleeding risk who have undergone percutaneous coronary intervention due to recent acute coronary syndrome.
Not a fit: Patients under 18 years old or those with contraindications to antiplatelet medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer antiplatelet therapy for high bleeding risk patients, reducing the likelihood of bleeding complications.
How similar studies have performed: While there have been studies exploring antiplatelet therapy adjustments, this specific de-escalation strategy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Participants fulfilling all the following inclusion criteria are eligible for the study: * 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. The presence of anyone of the following exclusion criteria will lead to exclusion of the participant: * Age \< 18 years * 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) * 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 * Enrolment of the investigator, his/her family members, employees * 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 non-compliance.
Where this trial is running
Messina and 1 other locations
- Azienda Ospedaliera Universitaria Gaetano Martino — Messina, Italy (Recruiting)
- Ospedale degli Infermi — Rivoli, Italy (Not_yet_recruiting)
Study contacts
- Study coordinator: Francesco Costa, MD, PhD
- Email: francesco.costa@unime.it
- Phone: +39090221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.