Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

• Status: Not yet recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Treatments: Aspirin; Clopidogrel; Prasugrel Hydrochloride; Ticagrelor

Criteria

Inclusion Criteria:

1. Patients who 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

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]