Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
NCT ID: NCT06535568
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
576 participants
INTERVENTIONAL
2026-01-10
2027-02-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single antiplatelet therapy
Drug-coated balloon
Essential pro (iVascular, Barcelona, Spain) paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
Single antiplatelet therapy (SAPT)
The antithrombotic regimen is single antiplatelet therapy (SAPT). The Investigator will decide if to use aspirin or clopidogrel, whereas ticagrelor or prasugrel are not recommended in our study population since no benefit (or even harm) has been shown by these drugs in head-to-head trials versus clopidogrel in elderly PCI populations. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
Dual antiplatelet therapy
Drug-coated balloon
Essential pro (iVascular, Barcelona, Spain) paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
Dual antiplatelet therapy (DAPT)
The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Drug-coated balloon
Essential pro (iVascular, Barcelona, Spain) paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
Single antiplatelet therapy (SAPT)
The antithrombotic regimen is single antiplatelet therapy (SAPT). The Investigator will decide if to use aspirin or clopidogrel, whereas ticagrelor or prasugrel are not recommended in our study population since no benefit (or even harm) has been shown by these drugs in head-to-head trials versus clopidogrel in elderly PCI populations. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
Dual antiplatelet therapy (DAPT)
The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age ≥ 75 years or age ≥ 18 years at high bleeding risk;
* Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels;
* Stable or unstable coronary syndromes;
* De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation);
* Informed consent to participate in the study given by the patient or impartial witness.
Exclusion Criteria
* Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated;
* Pregnancy at the time of hospitalization;
* Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer;
* ST-elevation myocardial infarction;
* Life expectancy \<12 months;
* Left ventricular ejection fraction \<30%;
* Visible thrombus at lesion site;
* Target lesion/vessel with any of the following characteristics:
* severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory);
* left main stem stenosis \>50%;
* target lesion is in the left main stem;
* chronic total occlusion with anticipated necessity of retrograde approach;
* lesion is in a bypass graft.
* History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs);
* History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;
* Acute gastrointestinal ulcers;
* Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);
* Severe renal impairment (eGFR \< 30 mL/min);
* Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST \> 2 x ULN or total bilirubin \>1.5 x ULN);
* Severe cardiac failure (NYHA grade III or IV);
* Combination with methotrexate at doses of 15 mg/week or more;
* Patients with baseline neutrophil counts \< 1500 cells/mm³;
* Breastfeeding women;
* Full-blown thyrotoxicosis;
* Patients with a very high risk of thrombosis.
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación EPIC
OTHER
Fondazione Ricerca e Innovazione Cardiovascolare ETS
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PICCOLETO IV-EPIC 38
Identifier Type: -
Identifier Source: org_study_id