Status:
NOT_YET_RECRUITING
Rivaroxaban for Slow Coronary Flow After PCI in STEMI
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Affiliated Hospital of Jiaxing University
The Second Affiliated Hospital of Jiaxing University
Conditions:
ST Elevation Myocardial Infarction
No-Reflow Phenomenon
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to learn if drug Rivaroxaban works to improve slow flow in STEMI patients after PCI in adults. It will also learn about the safety of drug Rivaroxaban. The main ques...
Detailed Description
The trial is a multicenter, prospective, randomized, open-label, controlled, pilot trial evaluating the efficacy and safety of rivaroxaban for improving slow coronary flow in ST-segment elevation myoc...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, regardless of gender;
- Patients with ST-segment elevation myocardial infarction (STEMI) (meeting the diagnostic criteria of the 2019 Chinese "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction");
- Patients undergoing percutaneous coronary intervention (PCI);
- Patients with slow flow after PCI (TIMI flow grade \> 0 but \< 3);
- Signed informed consent form and willingness to comply with follow-up.
Exclusion
- Presence of malignant tumors or diseases with a life expectancy of less than 1 year;
- Coagulation disorders, diagnosed or suspected hematological diseases (excluding mild or moderate anemia);
- Thrombocytopenia (platelet count \< 100 × 10⁹/L); history of severe gastrointestinal diseases or peptic ulcers; active bleeding within the past 3 months or major surgery history; history of intracranial hemorrhage or intracranial aneurysm;
- History of cerebral hemorrhage or ischemic stroke within the past 6 months;
- Patients with cardiogenic shock; systemic infections or immune system diseases; confirmed, highly suspected, or unable to rule out aortic dissection; severe uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg);
- Current use of rivaroxaban or requiring long-term anticoagulation therapy (e.g., atrial fibrillation);
- Patients with renal insufficiency (eGFR \< 15 mL/min/1.73m²) or hepatic insufficiency (Child-Pugh Class B or C);
- Lactating or pregnant women, or women of childbearing potential unable to use effective contraception during the study period;
- Patients with any contraindications or allergies to rivaroxaban, aspirin, clopidogrel, or ticagrelor;
- Participation in other clinical trials within the past 3 months;
- Other conditions deemed unsuitable for participation by the investigator.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07195812
Start Date
October 1 2025
End Date
May 1 2028
Last Update
September 29 2025
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