Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT06013020

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

Led by Zunyi Medical College · Updated on 2024-03-19

374

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ischemic chest discomfort for at least 30 minutes with at least 1-mm ST-segment elevation in anterior leads on a 12-lead ECG
  • Patients provide written informed consent prior to enrollment
Not Eligible

You will not qualify if you...

  • Intracranial, gastrointestinal, or urogenital bleeding within 6 months
  • Requiring oral anticoagulant therapy (e.g., atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)
  • Bleeding diathesis, thrombocytopenia (platelet <100,000/mL), hemoglobin <10 g/dL, or high bleeding risk based on CRUSADE score
  • Hepatic dysfunction with liver enzymes >3 times normal limit
  • Renal failure with eGFR <15 ml/min/1.73m2 or requiring dialysis
  • Severe chronic obstructive pulmonary disease
  • Severe bradycardia without pacemaker protection
  • Use of drugs interfering with CYP3A4 metabolism that interact with ticagrelor
  • Life expectancy less than 1 year

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China, 563003

Actively Recruiting

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Research Team

C

Cai De Jin, MD

CONTACT

Y

Yan Yan Jin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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