NCT06821191 Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study
| NCT ID | NCT06821191 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2025-03-10 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 78 participants in total. It began in 2025-03-10 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.
Eligibility Criteria
Inclusion Criteria: 1. Patients who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin with either prasugrel (10 mg qd) or ticagrelor (90 mg bid) as part of standard of care. In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI. 2. Age ≥18 years. 3. Provide written informed consent. Exclusion Criteria: 1. Prior history of stent thrombosis 2. Prior cerebrovascular event 3. PCI within 30 days 4. Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., \*2/\*2 or \*3/\*3), 5. 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) 6. Hemodynamic instability 7. Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel 8. Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL) 9. Known hemoglobinopathies or anemia (hemoglobin \<9 g/dL) 10. Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06821191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06821191 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06821191 currently recruiting?
Yes, NCT06821191 is actively recruiting participants. Contact the research team at Luis.Ortega@jax.ufl.edu for enrollment information.
Where is the NCT06821191 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT06821191 clinical trial?
NCT06821191 is sponsored by University of Florida. The trial plans to enroll 78 participants.