Status:
RECRUITING
Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus
Lead Sponsor:
Zunyi Medical College
Conditions:
STEMI - ST Elevation Myocardial Infarction
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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) pa...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
374 Patients enrolled
Trial Details
Trial ID
NCT06013020
Start Date
April 1 2024
End Date
December 31 2027
Last Update
March 19 2024
Active Locations (1)
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1
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563003