Tailoring Bleeding Reduction Approaches in Patients Undergoing Percutaneous Coronary Interventions: Comparative Pharmacodynamic Effects of Potent P2Y12 Inhibitor Monotherapy Versus Dual Antiplatelet Therapy De-escalation

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Patients who presented with chronic coronary syndrome, underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10 mg od) or ticagrelor (90 mg bid) for at least 30 days. Or patients that presented with an Acute coronary syndrome (ACS) event and underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10mg od) or ticagrelor (90mg bid) for 3 months or greater.

• Age ≥18 years old

• Provide written informed consent

Locations
United States
Florida
University of Florida
RECRUITING
Jacksonville
Contact Information
Primary
Dominick J Angiolillo, MD,PhD
dominick.angiolillo@jax.ufl.edu
+1-904-244-3378
Backup
Andrea Burton, MPH, CCRP
Andrea.Burton@jax.ufl.edu
+1-904-244-5617
Time Frame
Start Date: 2023-02-15
Estimated Completion Date: 2025-12-15
Participants
Target number of participants: 90
Treatments
Active_comparator: DAPT de-escalation
Aspirin 81-mg od and clopidogrel 75-mg qd.
Experimental: Potent P2Y12 monotherapy
Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.
Sponsors
Leads: University of Florida

This content was sourced from clinicaltrials.gov

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