Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216821
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2024-01-11
Brief Title:
OPT-CAD Score GUIded Dual ANtiplatelet De-esCalation Time
Sponsor:
Shenyang Northern Hospital
Organization:
Shenyang Northern Hospital
Study Overview
Official Title:
OPT-CAD Score Guided Dual Antiplatelet De-escalation Time in Patients With Acute Coronary Syndrome Undergoing Undergoing Percutaneous Coronary Intervention a Register-based Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPT-GUIDNACE
Brief Summary:
Monotherapy with a P2Y12 inhibitor after a minimum period of DAPT following percutaneous coronary intervention PCI is an emerging de-escalation antiplatelet strategy in recent years However the optimal timing for de-escalating DAPT in ACS patients undergoing PCI remains debated The OPT-CAD score is a risk stratification tool derived from Chinese patients which has been demonstrated superior predictive capabilities for ischemic events and all-cause mortality than the GRACE score Therefore we hypothesize that the OPT-CAD score can be used to guide the timing of the DAPT de-escalation strategy to monotherapy with P2Y12 inhibitors for ACS patients that is low-risk patients could be de-escalated after 1 month while high-risk patients could be de-escalated after 3 months so as to achieve individualized antithrombotic therapy and maximize patient benefit
Detailed Description:
Antiplatelet therapy is a cornerstone of secondary prevention in patients with coronary artery disease However as the use of more potent antithrombotic therapy it not only lowers ischemic risk but increases bleeding Therefore fully balancing the risks of thrombosis and bleeding to maximize patient benefit is the basis for antiplatelet therapy Although there are several scoring systems to assess the risk of thrombotic or bleeding such as GRACE score CRUSADE score PARIS score and ARC-HBR criteria the value of the above scoring systems from western populations in guiding dual antiplatelet therapy DAPT decisions has not been confirmed The previous guidelines recommend considering the PRECISE-DAPT score and DAPT score to guide DAPT duration but their practical application remains limited The 2020 ESC NSTE-ACS guidelines pointed out that there is still a gap between evidence and practice regarding whether risk-stratified treatment strategies can improve the prognosis of patients which urgently requires randomized controlled trials RCTs for validation
Monotherapy with a P2Y12 inhibitor after a minimum period of DAPT following percutaneous coronary intervention PCI is an emerging de-escalation strategy DAPT in recent years Previous RCTs such as STOPDAPT-2 SMART-CHOICE TICO and TWILIGHT have demonstrated that compared with the conventional 12-month DAPT regimen de-escalation of DAPT reduced the risk of bleeding without a significant increase in ischaemic events To be specific the intervention groups switched to ticagrelor monotherapy after 3 months of DAPT resulting in comparable ischemic event rates among both TICO trial enrolled ACS patients undergoing PCI and TWILIGHT trial enrolled high-risk patients undergoing PCI Meanwhile when STOPDAPT-2 trial enrolled low-risk patients undergoing PCI the results also indicated that clopidogrel monotherapy after 1 month of DAPT results in similar thrombotic event risks However when STOPDAPT-2 ACS trial enrolled ACS patients compared to the 12-month DAPT group the results showed that switching from 1- to 2-month DAPT to clopidogrel monotherapy resulted in an increased incidence of myocardial infarction Given these findings the optimal timing for de-escalation of DAPT in ACS patients undergoing PCI remain debated
The Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease OPT-CAD score a risk stratification tool derived from a real-world multicenter registration study of Chinese patients has better predictive performance for ischemic events and all-cause mortality at 1-year than those of The Global Acute Coronary Event Registration GRACE score Through the analysis of OPT-CAD population it was found that low-risk and medium-high risk patients with OPT-CAD scores accounted for about 23 and 13 respectively and the risk of major adverse cardiovascular events MACE in medium-high risk patients at 1 year follow-up was about 3 times that of low-risk patients Therefore we hypothesize that the OPT-CAD score can be used to guide the timing of DAPT de-escalation strategy to monotherapy with P2Y12 inhibitors for ACS patients that is low-risk patients could be de-escalated after 1 month while high-risk patients could be de-escalated after 3 months so as to achieve individualized antithrombotic therapy and maximize patient benefit
Monotherapy with a P2Y12 inhibitor after a minimum period of DAPT following percutaneous coronary intervention PCI is an emerging de-escalation strategy DAPT in recent years Previous RCTs such as STOPDAPT-2 SMART-CHOICE TICO and TWILIGHT have demonstrated that compared with the conventional 12-month DAPT regimen de-escalation of DAPT reduced the risk of bleeding without a significant increase in ischaemic events To be specific the intervention groups switched to ticagrelor monotherapy after 3 months of DAPT resulting in comparable ischemic event rates among both TICO trial enrolled ACS patients undergoing PCI and TWILIGHT trial enrolled high-risk patients undergoing PCI Meanwhile when STOPDAPT-2 trial enrolled low-risk patients undergoing PCI the results also indicated that clopidogrel monotherapy after 1 month of DAPT results in similar thrombotic event risks However when STOPDAPT-2 ACS trial enrolled ACS patients compared to the 12-month DAPT group the results showed that switching from 1- to 2-month DAPT to clopidogrel monotherapy resulted in an increased incidence of myocardial infarction Given these findings the optimal timing for de-escalation of DAPT in ACS patients undergoing PCI remain debated
The Optimal antiPlatelet Therapy for Chinese patients with Coronary Artery Disease OPT-CAD score a risk stratification tool derived from a real-world multicenter registration study of Chinese patients has better predictive performance for ischemic events and all-cause mortality at 1-year than those of The Global Acute Coronary Event Registration GRACE score Through the analysis of OPT-CAD population it was found that low-risk and medium-high risk patients with OPT-CAD scores accounted for about 23 and 13 respectively and the risk of major adverse cardiovascular events MACE in medium-high risk patients at 1 year follow-up was about 3 times that of low-risk patients Therefore we hypothesize that the OPT-CAD score can be used to guide the timing of DAPT de-escalation strategy to monotherapy with P2Y12 inhibitors for ACS patients that is low-risk patients could be de-escalated after 1 month while high-risk patients could be de-escalated after 3 months so as to achieve individualized antithrombotic therapy and maximize patient benefit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None