Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB

NANot yet recruitingINTERVENTIONAL
Enrollment

416

Participants

Timeline

Start Date

October 10, 2024

Primary Completion Date

October 10, 2025

Study Completion Date

December 20, 2026

Conditions
Coronary DiseaseHeart DiseasesCardiovascular DiseasesMyocardial IschemiaAtherosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary Artery DiseaseAcute Coronary SyndromeCoronary StenosisMolecular Mechanisms of Pharmacological ActionEnzyme InhibitorsMTOR InhibitorsProtein Kinase InhibitorsPhysiological Effects of DrugsImmunosuppressive AgentsAntineoplastic AgentsHigh Bleeding RiskSingle Antiplatelet TherapyDual Antiplatelet TherapyCyclooxygenase InhibitorsP2Y12 InhibitorPlatelet Aggregation InhibitorsAspirinClopidogrel
Interventions
DEVICE

Drug-coated balloon

Essential pro (iVascular, Barceona, 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.

DRUG

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.

DRUG

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.

All Listed Sponsors
collaborator

Fundación EPIC

OTHER

lead

Fondazione Ricerca e Innovazione Cardiovascolare ETS

OTHER

NCT06535568 - Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB | Biotech Hunter | Biotech Hunter