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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture, triggers platelet activation/aggregation 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 (2.5 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv) ST-segment elevation in anterior leads on a standard 12-lead electrocardiogram.

• Patients provide written informed consent prior to enrollment.

Locations
Other Locations
China
Affiliated Hospital of Zunyi Medical University
RECRUITING
Zunyi
Contact Information
Primary
Cai De Jin, MD
jincaide@zmu.edu.cn
86+178-0250-2582
Backup
Yan Yan Jin, MD
jinyanyan850925@163.com
86+157-7229-0925
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 374
Treatments
Experimental: Guided NOAC and DAPT
The first month: rivaroxaban 2.5 mg twice daily (if CR≥24) plus standard DAPT (ticagrelor 90 mg twice daily or clopidogrel 75 mg daily plus aspirin 100 mg daily).~The following 11 months: lower-dose ticagrelor 60 mg twice daily (45 mg twice daily if \<50 kg, ≥75 yrs) or clopidogrel (75 mg daily) plus aspirin (100 mg daily).
Experimental: Unguided DAPT
The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.
Sponsors
Leads: Zunyi Medical College

This content was sourced from clinicaltrials.gov

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