Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06535568 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

Study acronym: PIV-EPIC
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Primary completion date: Jan 10, 2026 to Jan 20, 2028
    • Study sites: 0 to 1
    • Study completion date: Feb 20, 2027 to Feb 20, 2028
    • Secondary endpoints revised (3)
    • Study description shortened, about 1 word
    • Study title expanded, about 3 words
  2. Start date: Oct 10, 2024 to Jan 10, 2026v3 Show 7 more changesShow less
    • Primary endpoints: 2 to 1
    • Enrollment target: 416 to 576
    • Primary completion date: Oct 10, 2025 to Jan 10, 2026
    • Study completion date: Dec 20, 2026 to Feb 20, 2027
    • Eligibility criteria expanded, about 167 words
    • Secondary endpoints expanded, about 20 words
    • Study description expanded, about 14 words
  3. Interventions: Drug-coated balloon (Device) to Drug-coated balloon (Device), Dual antiplatelet therapy (DAPT) (Drug), Single antiplatelet therapy (SAPT) (Drug)v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.
Trial Details
NCT Number NCT06535568
Lead Sponsor Fondazione Ricerca e Innovazione Cardiovascolare ETS
Collaborators: Fundación EPIC
Conditions
(from sponsor)		 Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease +17 more
Related terms Acute Coronary Syndrome, Arterial Occlusive Diseases, Atherosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Coronary Stenosis, Heart Diseases, Myocardial Ischemia, Vascular Diseases
Enrollment 576 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov