NCT07195812

Rivaroxaban for Slow Coronary Flow After PCI in STEMI

Evaluation of the Efficacy and Safety of Rivaroxaban in Improving Slow Coronary Flow After Percutaneous Coronary Intervention in STEMI Patients: A Multicenter, Prospective,Randomized, Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 questions it aims to answer are: Does drug Rivaroxaban Reduce the Corrected TIMI Frame Count (cTFC) in 1 Week After PCI ? Researchers will compare Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) to Dual Antiplatelet Therapy to see if drug Combination therapy with rivaroxaban, aspirin works to treat Slow Flow in STEMI Patients After PCI. Participants will: Take drug Combination therapy with rivaroxaban (2.5 mg administered twice daily), aspirin (100 mg administered daily), and clopidogrel (75 mg administered daily) or Dual Antiplatelet Therapy every day for 1 months. Visit the clinic in 7 days、30 days and 365 days for checkups and tests.

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 myocardial infarction (STEMI) patients after percutaneous coronary intervention (PCI). Patients with STEMI who have undergone PCI and exhibit slow coronary flow (TIMI flow grade \>0，and \< 3, ) are eligible for the clinical trial. Slow coronary flow will be quantitatively assessed using the corrected TIMI frame count (cTFC) method. The study consists of two parallel treatment groups, evaluating the clinical efficacy and safety of 30 days of combination antithrombotic therapy versus standard therapy, followed up to 365 days. The treatment groups are: Group 1 - Experimental Antithrombotic Therapy Eligible patients will receive a combination of rivaroxaban (2.5 mg orally twice daily) plus dual antiplatelet therapy (DAPT: aspirin 100 mg/day and clopidogrel 75 mg/day) for a total duration of 30 days (treatment period), followed by assessments at 7 days, 30 days, and 365 days (follow-up period). Group 2 - Standard Antithrombotic Therapy (Control) Eligible patients will receive standard DAPT (aspirin 100 mg/day and clopidogrel 75 mg/day or ticagrelor 90 mg twice daily) for a total duration of 30 days (treatment period), followed by assessments at 7 days, 30 days, and 365 days (follow-up period). The primary efficacy endpoint is the change in cTFC from baseline to within 1 week after PCI. Key secondary endpoints include the incidence of Major Adverse Cardiovascular Events (MACE) and bleeding events (assessed by BARC criteria) at 7 days, 30 days, and 365 days.

Conditions

• ST Elevation Myocardial Infarction
• No-Reflow Phenomenon

Interventions

Type	Name	Description
DRUG	Dual Antiplatelet (DAPT) Therapy	aspirin 100 mg daily plus clopidogrel 75 mg daily or ticagrelor 90 mg per dose, twice daily for 30 consecutive days
DRUG	Rivaroxaban	Rivaroxaban (2.5 mg twice daily) plus aspirin 100 mg daily plus clopidogrel 75 mg daily for 30 days

Timeline

• Start date: 2025-10-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2025-09-29
• Last updated: 2025-09-29