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SOLOPCINCT07164859

Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Start date changed from estimate of Oct 2025 to Mar 3, 2026
    • Eligibility criteria expanded, about 32 words
    • Site details revised
  2. Lead sponsor: University Hospital, Caen to Vincent ROULEv2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

net clinical benefit
Timeframe: 12 months after randomization

Secondary (3)

Major or clinically relevant non-major bleeding
Major cardiovascular and cerebrovascular events
Major bleeding (BARC 3 or 5)

Arms and interventions

standard DAPT durationActive comparator

Patients assigned to standard DAPT duration will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for at least 3 months after randomization or longer and followed by single antiplatelet therapy (aspirin or P2Y12 inhibitor, at the discretion of the local investigator after PCI)

short DAPTExperimental

Patients assigned to short DAPT will receive DAPT (with aspirin and a P2Y12 inhibitor: ticagrelor, prasugrel or clopidogrel for acute coronary syndrome, or clopidogrel for chronic coronary syndrome) for 7 days (after randomization) followed by P2Y12 inhibitor alone (ticagrelor, prasugrel or clopidogrel as indicated) for 12 months

Drugs: short dual antiplatelet therapy (DAPT) duration, Standard DAPT duration

Sites

1 site in 1 country

  • Caen University HospitalCaen, France