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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750758
• Other study ID #: HenanICE202203
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 1, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• rivaroxaban
rivaroxaban 2.5mg bid for 1m

Locations

Country	Name	City	State
China	Fuwai central China cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	late lumen loss ( LLL)	Evaluation of postoperative target vessel LLL at follow-up using QCA	6 months
Secondary	Vascular dissection healing	Re-use CAG to evaluate the vascular reexamination of the original dissection	6 months
Secondary	Minimum lumen area	using CAG	6 months
Secondary	Cardiovascular death	All deaths are counted as cardiovascular deaths unless there is a clear determination of other causes	6 months
Secondary	Target vessel myocardial infarction	CAG confirms	6 months
Secondary	Clinical-driven revascularization of target lesions	Clinical-driven revascularization of target lesions	6 months
Secondary	Bleeding events defined by BARC	Bleeding events defined by BARC	6 months