Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013020
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-02-28
Brief Title:
Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus
Sponsor:
Zunyi Medical College
Organization:
Zunyi Medical College
Study Overview
Official Title:
Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
To manage the ST-segment elevation myocardial infarction STEMI caused by plaque rupture triggers platelet activationaggregation and thrombin generation requires dual platelet and coagulation pathway inhibition However triple antithrombotic therapy with standard dual antiplatelet therapy DAPT and oral anticoagulant OAC in the STEMI setting is a challenge since that increase in potential risk of bleeding
Although the incidence of left ventricular thrombus LVT formation after STEMI decreased in modern reperfusion therapy including primary percutaneous coronary intervention PCI remains at 4 to 26 especially that complicated by anterior STEMI The recommendation of an OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile and prevent LVT formation is challenging since insufficient evidence is available from randomized trials
Century Clot analyzer is point-of-care testing that could assess the coagulate state normal hypo-coagulable or hyper-coagulable states according to clot rate CR value Whether Century Clot-guided rivaroxaban prophylactic therapy 25 mg twice daily if the hypercoagulable state defined as CR 24 in combination with standard DAPT could reduce LVT formation without increasing major bleeding is uncertain
Although the incidence of left ventricular thrombus LVT formation after STEMI decreased in modern reperfusion therapy including primary percutaneous coronary intervention PCI remains at 4 to 26 especially that complicated by anterior STEMI The recommendation of an OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile and prevent LVT formation is challenging since insufficient evidence is available from randomized trials
Century Clot analyzer is point-of-care testing that could assess the coagulate state normal hypo-coagulable or hyper-coagulable states according to clot rate CR value Whether Century Clot-guided rivaroxaban prophylactic therapy 25 mg twice daily if the hypercoagulable state defined as CR 24 in combination with standard DAPT could reduce LVT formation without increasing major bleeding is uncertain
Detailed Description:
The Prophylactic Rivaroxaban Therapy for Post STEMI Complicating Left VENtricular Thrombus PREVENT study is designed to investigate the safety and efficacy of Century Clot-guided additional low-dose rivaroxaban plus DAPT as an optimal antithrombotic strategy for preventing LVT formation after anterior STEMI undergoing primary PCI
All eligible STEMI patients will be received standard DAPT ticagrelor or clopidogrel plus aspirin At post-PCI 12-24 hours to be randomly assigned into Century Clot CR-guided rivaroxaban 25 mg twice daily for 1 month in combination with DAPT and standard DAPT Omitting rivaroxaban at post-PCI 1 month and both groups are following a tailored-ticagrelor with dose reduction strategy 60 mg bid or 45 mg bid if 50 kg 75 yrs or clopidogrel 75 mg qd plus aspirin 100 mg qd for further 11 months The clinical outcome is the incidence of LVT formation and net adverse clinical events NACEs composite of cardiac death non-fatal myocardial infarction TVRTLR stroke and major bleeding at post-STEMI 1 month as well as at 12-month clinical follow-ups
In PREVENT study the investigators hypothesize that Century Clot CR-guided additional rivaroxaban prophylactic therapy could reduce LVT formation without increasing bleeding after anterior STEMI when compared with standard DAPT
All eligible STEMI patients will be received standard DAPT ticagrelor or clopidogrel plus aspirin At post-PCI 12-24 hours to be randomly assigned into Century Clot CR-guided rivaroxaban 25 mg twice daily for 1 month in combination with DAPT and standard DAPT Omitting rivaroxaban at post-PCI 1 month and both groups are following a tailored-ticagrelor with dose reduction strategy 60 mg bid or 45 mg bid if 50 kg 75 yrs or clopidogrel 75 mg qd plus aspirin 100 mg qd for further 11 months The clinical outcome is the incidence of LVT formation and net adverse clinical events NACEs composite of cardiac death non-fatal myocardial infarction TVRTLR stroke and major bleeding at post-STEMI 1 month as well as at 12-month clinical follow-ups
In PREVENT study the investigators hypothesize that Century Clot CR-guided additional rivaroxaban prophylactic therapy could reduce LVT formation without increasing bleeding after anterior STEMI when compared with standard DAPT
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?:
False
Is an FDA AA801 Violation?:
None