Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588595
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
The Switching Antiplatelet-9 SWAP-9 Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWAP-9
Brief 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
Detailed 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 are preferred over clopidogrel due to their superior effectiveness in reducing ischemic events including stent thrombosis Nevertheless this ischemic benefit comes at the risk of an increased risk of bleeding due to the enhanced antiplatelet potency of prasugrel and ticagrelor Importantly bleeding complications have significant prognostic implications including increased mortality highlighting the importance of identifying antiplatelet strategies associated with an optimal balance of reducing bleeding risk while maintaining ischemic protection
Most recurrent ischemic events including stent thrombosis occur early after the index event ie 1-3 months post-PCI Accordingly it is common in clinical practice to use antiplatelet treatment regimens consisting of potent agents during the first months ie enhanced platelet reactivity after PCI followed by approaches with less potent platelet inhibition This bleeding avoidance strategy is defined as de-escalation and is endorsed by practice guidelines De-escalation can occur using different strategies including reducing platelet inhibition by a discontinuing an antiplatelet agent eg discontinuing either the P2Y12 inhibitor or aspirin or b switching from a more potent to a less potent P2Y12 inhibitor Currently de-escalation by aspirin discontinuation and maintaining P2Y12 inhibitor monotherapy is a guideline-recommended strategy regardless of bleeding risk and clinical presentation and appears to be a safer approach than discontinuation of a P2Y12 inhibitor and maintaining aspirin monotherapy De-escalation by switching from a more potent ie prasugrel or ticagrelor to a less potent P2Y12 inhibitor ie clopidogrel can be performed either in a guided or unguided fashion Guided de-escalation can use either genetic or platelet function tests to tailor antiplatelet therapy based on individual patient drug response providing a personalized approach In contrast unguided de-escalation occurs without the use of these tests Genetic testing for cytochrome P450 2C19 CYP2C19 polymorphisms has the advantage over PFT in that it allows for the prediction of the response of clopidogrel without patients having to be on treatment The accuracy of genetic testing to predict clopidogrel response can be improved by integrating clinical factors In particular the Age Body Mass Index Chronic Kidney Disease Diabetes Mellitus and Genotyping ABCD-GENE score is a simple tool designed to identify patients at risk of impaired clopidogrel response and has been validated in several studies However to date there are no prospective randomized studies evaluating the pharmacodynamic PD effects of an ABCD-GENE score-guided de-escalation strategy in patients undergoing PCI Furthermore no study has compared two de-escalation strategies guided by the ABCD-GENE score
Most recurrent ischemic events including stent thrombosis occur early after the index event ie 1-3 months post-PCI Accordingly it is common in clinical practice to use antiplatelet treatment regimens consisting of potent agents during the first months ie enhanced platelet reactivity after PCI followed by approaches with less potent platelet inhibition This bleeding avoidance strategy is defined as de-escalation and is endorsed by practice guidelines De-escalation can occur using different strategies including reducing platelet inhibition by a discontinuing an antiplatelet agent eg discontinuing either the P2Y12 inhibitor or aspirin or b switching from a more potent to a less potent P2Y12 inhibitor Currently de-escalation by aspirin discontinuation and maintaining P2Y12 inhibitor monotherapy is a guideline-recommended strategy regardless of bleeding risk and clinical presentation and appears to be a safer approach than discontinuation of a P2Y12 inhibitor and maintaining aspirin monotherapy De-escalation by switching from a more potent ie prasugrel or ticagrelor to a less potent P2Y12 inhibitor ie clopidogrel can be performed either in a guided or unguided fashion Guided de-escalation can use either genetic or platelet function tests to tailor antiplatelet therapy based on individual patient drug response providing a personalized approach In contrast unguided de-escalation occurs without the use of these tests Genetic testing for cytochrome P450 2C19 CYP2C19 polymorphisms has the advantage over PFT in that it allows for the prediction of the response of clopidogrel without patients having to be on treatment The accuracy of genetic testing to predict clopidogrel response can be improved by integrating clinical factors In particular the Age Body Mass Index Chronic Kidney Disease Diabetes Mellitus and Genotyping ABCD-GENE score is a simple tool designed to identify patients at risk of impaired clopidogrel response and has been validated in several studies However to date there are no prospective randomized studies evaluating the pharmacodynamic PD effects of an ABCD-GENE score-guided de-escalation strategy in patients undergoing PCI Furthermore no study has compared two de-escalation strategies guided by the ABCD-GENE score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None