Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorUlsan University Hospital
About this trial
The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon.
The main questions it aims to answer are:
Does stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment?
Researchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up.
Participants will:
Be randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time
Eligibility criteria
Qualifiers
Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.
Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.
Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.
Patients who have not experienced major bleeding since the index DCB treatment.
Disqualifiers
Patients with concomitant vascular disease requiring long-term antiplatelet therapy.
Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.
Patients who are participating in another drug or coronary device clinical study at the time of enrollment.
Trial design
Treatments tested in this trial
- Stop Antiplatelet
- Continue Antiplatelet
Treatment groups
1,042 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov