Comparing antiplatelet therapies after heart procedures
Comparison of ABCD-GENE Score-Guided Versus Unguided DAPT De-Escalation: A Prospective Randomized Pharmacodynamic Study in Patients Undergoing PCI The Switching Antiplatelet-9 (SWAP-9) Study
This study is testing whether a new way of managing blood-thinning medications after heart procedures can help people with heart issues avoid problems while also reducing the risk of bleeding.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06588595 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of guided versus unguided de-escalation strategies of dual antiplatelet therapy (DAPT) in patients who have undergone percutaneous coronary intervention (PCI). It focuses on patients with acute coronary syndrome and evaluates the balance between reducing the risk of ischemic events and minimizing bleeding complications. Participants will be randomized to receive either prasugrel or ticagrelor monotherapy or a combination of aspirin and clopidogrel after a specified period post-PCI. The study aims to identify the optimal antiplatelet strategy for improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone PCI and are currently on maintenance DAPT.
Not a fit: Patients with a history of stent thrombosis or those currently on anticoagulant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and safer antiplatelet treatment strategies for patients with coronary arterial disease.
How similar studies have performed: Other studies have shown promising results with similar approaches to antiplatelet therapy, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who have undergone PCI and are on maintenance treatment with DAPT, composed of low-dose aspirin (81mg qd) with either prasugrel (10 mg qd) or ticagrelor (90 mg bid). 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. PCI within 30 days 3. 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) 4. Hemodynamic instability 5. Hypersensitivity to clopidogrel 6. Known platelet count less than 80x10\^6/mL 7. Known hemoglobin less than 9 g/dL 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
- Study coordinator: Luis Ortega, MD, PhD
- Email: Luis.Ortega@jax.ufl.edu
- Phone: 904-244 2060
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.