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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

24 Versus 12-Month Dual Antiplatelet Therapy After Drug-Eluting Stent in Patients With Elevated Lipoprotein(a) Levels: A Prospective, Multicenter, Double-Blind, Placebo-Controlled Randomized Trial

NCT06014060

Elevated Lipoprotein(a) Level Coronary Artery Disease Drug-Eluting Stent +1 more

RECRUITING NA

Intensive Statin Therapy in Patients With AMI

NCT01923077

Acute Myocardial Infarction

UNKNOWN PHASE2

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study

NCT02619760

Coronary Artery Disease

COMPLETED PHASE4

Effects of Intensive Statin Treatment on Left Ventricular Function

NCT01936103

Acute Anterior Myocardial Infarction

UNKNOWN PHASE4

Perioperative Intensive Statin Therapy for Neuroprotection in TAVR（PISTNT）

NCT07087379

Aortic Stenosis Cerebral Ischaemic Injury

NOT_YET_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

STEMI - ST Elevation Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

NOAC+DAPT

Intervention Type DRUG

Century Clot-guided rivaroxaban plus DAPT.

Unguided DAPT

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

Group Type EXPERIMENTAL

DAPT

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NOAC+DAPT

Century Clot-guided rivaroxaban plus DAPT.

Intervention Type DRUG

DAPT

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rivaroxaban + ticagrelor or clopidogrel + aspirin Ticagrelor or clopidogrel + aspirin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No