Rivaroxaban Combined With DAPT Versus DAPT Alone After Drug-coated Balloon Angioplasty

• Status: Not yet recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The target population of this interventional study was ACS patients with drug-coated balloons. The main discussion : 1.1 months of rivaroxaban combined with dual antiplatelet therapy compared with dual antiplatelet therapy alone, late lumen loss at 6 months. 2. To determine the safety of the regimen with bleeding events as the end point. Subjects were randomly assigned to two groups, one receiving routine DAPT for six months and one receiving DAPT plus one month of rivaroxaban 2.5 mg bid

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Institute of Cardiovascular Epidemiology
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

• ACS patients who meet the indications of percutaneous coronary intervention

• The reference diameter of the target vessel was ≥2.75mm

• Target lesions were treated with a drug-coated balloon catheter (DCB) for PCI

• According to IVUS assessment, the target lesions were dissected and accumulated medium without affecting distal blood flow

Exclusion Criteria:

• <18 or >60 years old

• Bridging vessels or stent restenosis

• Unable to sign written informed consent

• Female patients during pregnancy or lactation (for women who have not stopped menstruation, pregnancy test should be performed within 7 days prior to enrollment in this study)

• Antiplatelet agents and anticoagulants are not available; Have heparin, contrast agent and other allergies

• The subjects were participating in other uncompleted clinical trials

• Scheduled elective surgery

• Life expectancy is less than 1 year

• Patients with high blood risk

• Has long-term oral anticoagulant therapy adaptation

• Cardiogenic shock

• Patients with severe intraoperative dissection or hematoma requiring stent rescue