NCT05750758Completed
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
Source: ClinicalTrials.gov · Last updated 23 Feb 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 140 (actual)
- First submitted
- 20 Feb 2023
- Start date
- 20 Feb 2023
- Primary completion date
- 10 Aug 2023
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Diseases
- Coronary artery disease
- NCT number
- NCT05750758
What you commit to
- Study type: Interventional
- Participants enrolled: 140
- From 20 Feb 2023 to the primary completion date, 10 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Scheduled elective surgery
- Has long-term oral anticoagulant therapy adaptation
Other illness
- Antiplatelet agents and anticoagulants are not available; Have heparin, contrast agent and other allergies
Age
- \<18 or \>60 years old
Other
- Bridging vessels or stent restenosis
- Unable to sign written informed consent
- The subjects were participating in other uncompleted clinical trials
- Life expectancy is less than 1 year
- Patients with high blood risk
- Cardiogenic shock
- Patients with severe intraoperative dissection or hematoma requiring stent rescue
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Central China Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.