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
University of Florida
Summary
The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).
Description
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor represents the guideline-recommended treatment for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). In ACS patients undergoing PCI, DAPT is initiated during the index event and continued for up to one year to prevent stent-related complications and ischemic recurrences. Currently, clopidogrel, prasugrel, and ticagrelor are the three available oral P2Y12 inhibitors. Among ACS patients undergoing PCI, prasugrel and ticagrelor…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPrasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel
After at least 30 days of DAPT \[with aspirin 81-mg qd and a potent P2Y12 inhibitor (prasugrel 10 mg qd or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients with an ABCD-GENE 10 or more will continue prasugrel 10 mg qd/ticagrelor 90 mg BID and drop aspirin; and patients with an ABCD-GENE less than10 will switch from prasugrel/ticagrelor-based DAPT to aspirin 81 mg qd plus clopidogrel 75 mg qd.
- DrugAspirin plus clopidogrel
After at least 30 days of DAPT \[with aspirin 81 mg qd and a potent P2Y12 inhibitor (prasugrel 10 mg qd or ticagrelor 90 mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will switch from prasugrel/ticagrelor-based DAPT to aspirin 81 mg qd plus clopidogrel 75 mg qd, irrespective of ABCD-GENE score.
Location
- University of FloridaJacksonville, Florida