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

NCT06013020 | Recruiting Phase 4

• 1 other identifier: PREVENT
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI

Outcome Measures

Primary Outcomes (2)

• The incidence of left ventricular thrombus (LVT) formation.

  Efficacy endpoint

  At 1 month

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

  Safety endpoint

  At 1 month

Secondary Outcomes (1)

• NACE (net adverse clinical event)

  At 12 months

Study Arms (2)

Guided NOAC and DAPT

EXPERIMENTAL

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

Unguided DAPT

EXPERIMENTAL

The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.

Drug: DAPT

Interventions

NOAC+DAPT DRUG

Century Clot-guided rivaroxaban plus DAPT.

Also known as: Rivaroxaban + ticagrelor or clopidogrel + aspirin

Guided NOAC and DAPT

DAPT DRUG

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

Also known as: Ticagrelor or clopidogrel + aspirin

Unguided DAPT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zunyi Medical College: lead

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

RECRUITING

Related Publications (3)

• Camaj A, Fuster V, Giustino G, Bienstock SW, Sternheim D, Mehran R, Dangas GD, Kini A, Sharma SK, Halperin J, Dweck MR, Goldman ME. Left Ventricular Thrombus Following Acute Myocardial Infarction: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Mar 15;79(10):1010-1022. doi: 10.1016/j.jacc.2022.01.011.

  PMID: 35272796 BACKGROUND

• Weitz JI, Angiolillo DJ, Geisler T, Heitmeier S. Dual Pathway Inhibition for Vascular Protection in Patients with Atherosclerotic Disease: Rationale and Review of the Evidence. Thromb Haemost. 2020 Aug;120(8):1147-1158. doi: 10.1055/s-0040-1713376. Epub 2020 Jun 28.

  PMID: 32594508 BACKGROUND

• Yang WX, Lai CL, Chen FH, Wang JR, Ji YR, Wang DX. The value of Sonoclot detection technology to guide the clinical medication of the perioperative anticoagulation and antiplatelet therapy in patients with acute myocardial infarction undergoing emergent PCI. Exp Ther Med. 2017 Jun;13(6):2917-2921. doi: 10.3892/etm.2017.4336. Epub 2017 Apr 13.

  PMID: 28587360 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Rivaroxaban; Ticagrelor; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Pyridines; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Cai De Jin, MD

  Zunyi Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cai De Jin, MD

CONTACT

86+178-0250-2582; jincaide@zmu.edu.cn

Yan Yan Jin, MD

CONTACT

86+157-7229-0925; jinyanyan850925@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: August 28, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

CN (1)