Comparing bleeding reduction methods for patients undergoing heart procedures

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

This study is testing two different ways to reduce bleeding during heart procedures for patients with coronary artery disease to see which method works better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT05681702 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates two different strategies for reducing bleeding complications in patients with coronary artery disease who are undergoing percutaneous coronary intervention (PCI). The study compares DAPT de-escalation, which involves switching from a potent P2Y12 inhibitor to clopidogrel while maintaining aspirin, with potent P2Y12 inhibitor monotherapy, where aspirin is dropped but the potent inhibitor is maintained. Both strategies aim to minimize bleeding risks while preserving the effectiveness of preventing ischemic events. The trial seeks to fill a gap in comparative assessments between these two approaches, which have been shown to be effective in previous studies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have undergone PCI and have been on dual antiplatelet therapy for at least 30 days.

Not a fit: Patients with a history of stent thrombosis, those on anticoagulant therapy, or individuals with severe bleeding disorders will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing PCI by minimizing bleeding complications.

How similar studies have performed: Previous studies have shown success with similar bleeding reduction strategies, but this trial aims to provide direct comparisons that are currently lacking.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Age ≥18 years old
3. Provide written informed consent

Exclusion Criteria:

1. Prior history of stent thrombosis
2. On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
3. Renal failure requiring dialysis
4. Patients with known bleeding diathesis or coagulation disorders
5. Known severe hepatic impairment
6. Hemodynamic instability
7. Hypersensitivity to clopidogrel
8. Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\]

Where this trial is running

Jacksonville, Florida

• University of Florida — Jacksonville, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Dominick J Angiolillo, MD,PhD — University of Florida College of Medicine Jacksonville
• Study coordinator: Dominick J Angiolillo, MD,PhD

Conditions: Coronary Artery Disease, Percutaneous coronary intervention, Dual antiplatelet therapy, Bleeding