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

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

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: rivaroxaban

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: rivaroxaban; rivaroxaban 2.5mg bid for 1m
No Intervention: DAPT; aspirin 100 mg qd + ticagrelor 90 mg bid for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
late lumen loss ( LLL)	Evaluation of postoperative target vessel LLL at follow-up using QCA	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	All deaths are counted as cardiovascular deaths unless there is a clear determination of other causes	6 months
Target vessel myocardial infarction	CAG confirms	6 months
Vascular dissection healing	Re-use CAG to evaluate the vascular reexamination of the original dissection	6 months
Minimum lumen area	using CAG	6 months
Clinical-driven revascularization of target lesions	Clinical-driven revascularization of target lesions	6 months
Bleeding events defined by BARC	Bleeding events defined by BARC	6 months

Collaborators and Investigators

• Sponsor: Henan Institute of Cardiovascular Epidemiology
• Investigators: Study Chair: Muwei Li, MD, Fuwai central China cardiovascular hospotial

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban
• Other Study ID Numbers: HenanICE202203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No