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

NCT ID: NCT05750758

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2023-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

DAPT+rivaroxaban

Rivaroxaban 2.5 mg bid + aspirin 100 mg qd + ticagrelor 90 mg bid was used for 1 month after operation, and then aspirin 100 mg + ticagrelor 90 mg bid was used for 5 months.

Group Type: EXPERIMENTAL

rivaroxaban

Intervention Type: DRUG

rivaroxaban 2.5mg bid for 1m

DAPT

aspirin 100 mg qd + ticagrelor 90 mg bid for 6 months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

rivaroxaban

rivaroxaban 2.5mg bid for 1m

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Institute of Cardiovascular Epidemiology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muwei Li, MD

Role: STUDY_CHAIR

Fuwai central China cardiovascular hospotial

Locations

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Countries

China

Other Identifiers

HenanICE202203

Identifier Type: -

Identifier Source: org_study_id