NCT06013020 Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus
| NCT ID | NCT06013020 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Zunyi Medical College |
| Condition | STEMI - ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 374 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 374 participants in total. It began in 2024-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Cai De Jin, MD
PRINCIPAL INVESTIGATOR
Zunyi Medical College
Frequently Asked Questions
Who can join the NCT06013020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying STEMI - ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06013020 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06013020 currently recruiting?
Yes, NCT06013020 is actively recruiting participants. Contact the research team at jincaide@zmu.edu.cn for enrollment information.
Where is the NCT06013020 trial being conducted?
This trial is being conducted at Zunyi, China.
Who is sponsoring the NCT06013020 clinical trial?
NCT06013020 is sponsored by Zunyi Medical College. The principal investigator is Cai De Jin, MD at Zunyi Medical College. The trial plans to enroll 374 participants.