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

March 16, 2024 updated by: Cai De Jin, MD, Zunyi Medical College

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 (2.5 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, TVR/TLR, 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 Type

Interventional

Enrollment (Estimated)

374

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563003
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cai De Jin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • Renal failure (eGFR <15 ml/min/1.73m2 or requiring dialysis)
  • Severe chronic obstructive pulmonary disease
  • Severe bradycardia (sick sinus syndrome or high degree atrioventricular block without pacemaker protection)
  • Drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin
  • Life expectancy < 1 year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Drug: NOAC+DAPT
Century Clot-guided rivaroxaban plus DAPT.
Other Names:
  • Rivaroxaban + ticagrelor or clopidogrel + aspirin
Experimental: Unguided DAPT
The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.
Drug: DAPT
Standard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.
Other Names:
  • Ticagrelor or clopidogrel + aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of left ventricular thrombus (LVT) formation.
Time Frame: At 1 month
Efficacy endpoint
At 1 month
The incidence of clinically significant bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.
Time Frame: At 1 month
Safety endpoint
At 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NACE (net adverse clinical event)
Time Frame: At 12 months
The incidence of NACE, including cardiac death, non-fatal myocardial infarction, target vessel/lesion revascularization, LVT formation, systemic embolism or stroke, and major bleeding.
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zunyi Medical College

Investigators

  • Principal Investigator: Cai De Jin, MD, Zunyi Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 28, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT (Janssen Biotech Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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