NCT05750758

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

A Randomized Controlled Trial of Rivaroxaban Combined With Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone 1 Month After Drug-coated Balloon Angioplasty in Patients With Acute Coronary Syndrome Without High Bleeding Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Henan Institute of Cardiovascular Epidemiology · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

Drug-coated balloon ( DCB ) is to apply anti-intimal hyperplasia drugs to the surface of the balloon. When the balloon reaches the diseased blood vessel and is stretched and expanded, it contacts the intima of the blood vessel wall. By tearing the intima of the blood vessel and pressing, the transfer drug is quickly released to the intima of the blood vessel, thereby preventing restenosis after vascular intervention. Pretreatment is a key step in the use of drug balloons in situ macroangiopathy. At present, it is required that the residual stenosis of the lesion during pretreatment is ≤ 30 %, and there is no distal blood flow restrictive dissection and hematoma. The relationship between dissection hematoma and residual stenosis is difficult to deal with. Some small dissections are beneficial to the absorption of DCB anti-proliferative drugs by the vascular wall. The larger dissection may cause the thrombus to persist in the vascular wall, resulting in late lumen loss after organization. Rivaroxaban is a new oral anticoagulant, which is gradually used in the treatment of coronary heart disease. At present, there is no clinical study on the prognosis of vascular dissection in DCB. Based on the above research background, we designed the following trial, aimed to study in ACS population, vascular lumen access + hemorrhagic events as the end point, try to clear 1 month rivaroxaban combined with dual antiplatelet therapy compared with single dual antiplatelet therapy effect.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
DRUG	rivaroxaban	rivaroxaban 2.5mg bid for 1m

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-08-10
• Completion: 2023-12-01
• First posted: 2023-03-02
• Last updated: 2024-02-23

Locations

1 site across 1 country: China