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

Primary Purpose

STEMI - ST Elevation Myocardial Infarction

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
NOAC+DAPT
DAPT
Sponsored by
Zunyi Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for STEMI - ST Elevation Myocardial Infarction focused on measuring Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital of Zunyi Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Guided NOAC and DAPT

Unguided DAPT

Arm Description

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).

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

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
February 28, 2023
Last Updated
August 25, 2023
Sponsor
Zunyi Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT06013020
Brief Title
Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Anticipated)
Primary Completion Date
August 28, 2025 (Anticipated)
Study Completion Date
September 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zunyi Medical College

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction
Keywords
Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
374 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guided NOAC and DAPT
Arm Type
Experimental
Arm Description
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).
Arm Title
Unguided DAPT
Arm Type
Experimental
Arm Description
The first month: standard DAPT. The following 11 months: lower-dose ticagrelor or clopidogrel plus aspirin.
Intervention Type
Drug
Intervention Name(s)
NOAC+DAPT
Other Intervention Name(s)
Rivaroxaban + ticagrelor or clopidogrel + aspirin
Intervention Description
Century Clot-guided rivaroxaban plus DAPT.
Intervention Type
Drug
Intervention Name(s)
DAPT
Other Intervention Name(s)
Ticagrelor or clopidogrel + aspirin
Intervention Description
Standard DAPT for 1 month, following lower-dose ticagrelor or clopidogrel plus aspirin for 11 months.
Primary Outcome Measure Information:
Title
The incidence of left ventricular thrombus (LVT) formation.
Description
Efficacy endpoint
Time Frame
At 1 month
Title
The incidence of clinically significant bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria.
Description
Safety endpoint
Time Frame
At 1 month
Secondary Outcome Measure Information:
Title
NACE (net adverse clinical event)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cai De Jin, MD
Phone
86+178-0250-2582
Email
jincaide@zmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Yan Jin, MD
Phone
86+157-7229-0925
Email
jinyanyan850925@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cai De Jin, MD
Organizational Affiliation
Zunyi Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cai De Jin, MD
Phone
86+178-0250-2582
Email
jincaide@zmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yan Yan Jin, MD
Phone
86+157-7229-0925
Email
jinyanyan850925@163.com
First Name & Middle Initial & Last Name & Degree
Cai De Jin, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35272796
Citation
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.
Results Reference
background
PubMed Identifier
32594508
Citation
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.
Results Reference
background
PubMed Identifier
28587360
Citation
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.
Results Reference
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Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus

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