Clinical trial NCT05750758: Rivaroxaban Combined With DAPT Versus DAPT Alone After Drug-coated Balloon Angioplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Henan Institute of Cardiovascular Epidemiology
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: late lumen loss ( LLL)
timeFrame: 6 months
Secondary outcomes:
measure: Vascular dissection healing
timeFrame: 6 months
measure: Minimum lumen area
timeFrame: 6 months
measure: Cardiovascular death
timeFrame: 6 months
measure: Target vessel myocardial infarction
timeFrame: 6 months
measure: Clinical-driven revascularization of target lesions
timeFrame: 6 months
measure: Bleeding events defined by BARC
timeFrame: 6 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fuwai central China cardiovascular Hospital
state: Henan
Study officials:
affiliation: Fuwai central China cardiovascular hospotial
name: Muwei Li, MD
role: STUDY_CHAIR
References: