About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Intracranial, gastrointestinal, or urogenital bleeding within 6 months
Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism);
Bleeding diathesis, thrombocytopenia (platelet <100,000/mL) or hemoglobin <10 g/dL, and CRUSADE score-based high bleeding risk
Hepatic dysfunction (serum liver enzyme>3 times the normal limit)
Trial design
Parallel
Treatments tested in this trial
NOAC+DAPT
DrugCentury Clot-guided rivaroxaban plus DAPT.
DAPT
DrugStandard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.
Treatment groups
Trial outcomes
Primary outcomes
The incidence of left ventricular thrombus (LVT) formation.
Efficacy endpoint
The incidence of clinically significant bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.
Safety endpoint
Secondary outcomes
NACE (net adverse clinical event)
The incidence of NACE, including cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, LVT formation, systemic embolism or stroke, and major bleeding.
Sponsors and contacts
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