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

NCT05750758 | Completed DMC

• 1 other identifier: HenanICE202203
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• late lumen loss ( LLL)

  Evaluation of postoperative target vessel LLL at follow-up using QCA

  6 months

Secondary Outcomes (6)

• Vascular dissection healing

  6 months

• Minimum lumen area

  6 months

• Cardiovascular death

  6 months

• Target vessel myocardial infarction

  6 months

• Clinical-driven revascularization of target lesions

  6 months

Study Arms (2)

DAPT+rivaroxaban

EXPERIMENTAL

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

DAPT

NO INTERVENTION

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

Interventions

rivaroxaban DRUG

rivaroxaban 2.5mg bid for 1m

DAPT+rivaroxaban

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Muwei Li, MD

  Fuwai central China cardiovascular hospotial

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: February 20, 2023
• Primary Completion: August 10, 2023
• Study Completion: December 1, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)