Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZunyi Medical College

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • NOAC+DAPT

    Drug

    Century Clot-guided rivaroxaban plus DAPT.

  • DAPT

    Drug

    Standard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.

Treatment groups

374 Participants
are divided into 2 treatment groups
Group A: Guided NOAC and DAPTExperimental treatment 1 intervention
Group B: Unguided DAPTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of left ventricular thrombus (LVT) formation.

Efficacy endpoint

Time frame
At 1 month
2

The incidence of clinically significant bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.

Safety endpoint

Time frame
At 1 month

Secondary outcomes

1

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.

Time frame
At 12 months

Other outcomes

Sponsors and contacts

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