Using Rivaroxaban to Prevent Thrombus After Heart Attack
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
This study tests if adding a low dose of rivaroxaban to standard heart medications can help prevent blood clots in patients who have just had a heart attack.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 374 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Zunyi Medical College Academic / other |
| Locations | 1 site (Zunyi, Guizhou) |
| Trial ID | NCT06013020 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and effectiveness of using a Century Clot-guided low-dose rivaroxaban in combination with standard dual antiplatelet therapy (DAPT) to prevent left ventricular thrombus (LVT) formation in patients who have experienced an anterior ST-segment elevation myocardial infarction (STEMI) and undergone primary percutaneous coronary intervention (PCI). Eligible patients will receive standard DAPT and will be randomly assigned to receive either the additional rivaroxaban or continue with DAPT alone. The study aims to evaluate the incidence of LVT and other adverse clinical events at one month and twelve months post-STEMI. The goal is to optimize antithrombotic therapy while minimizing bleeding risks.
Who should consider this trial
Good fit: Ideal candidates are patients who have experienced anterior STEMI and are undergoing primary PCI.
Not a fit: Patients with a history of significant bleeding, those requiring anticoagulation therapy for other conditions, or those with severe hepatic or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of left ventricular thrombus formation in patients recovering from STEMI.
How similar studies have performed: While there is limited evidence from randomized trials on this specific approach, other studies have explored similar antithrombotic strategies with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Zunyi, Guizhou
- Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
Study contacts
- Principal investigator: Cai De Jin, MD — Zunyi Medical College
- Study coordinator: Cai De Jin, MD
- Email: jincaide@zmu.edu.cn
- Phone: 86+178-0250-2582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.