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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorVincent ROULE

About this trial

The goal of this clinical trial is to learn if reducing the duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (short treatment regimen, stopping aspirin at day 7) is as safe and efficient as the standard DAPT duration (standard treatment regimen) in elderly patients ≥ 65 years.

The main questions it aims to answer are:

Does the reduction of the duration of DAPT reduces rates of bleeding without increasing the risk of cardiovascular events? Researchers will compare a short treatment by DAPT (7 days, followed by single antiplatelet therapy) to a standard treatment duration by DAPT (3 to 12 months) after successful percutaneous coronary intervention with ≥ 1 drug-eluting stent.

Participants will:

* Take aspirin for 7 days in one group or 3 to 12 months in another group * Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge * Keep a diary of any bleeding or cardiovascular events occurring during the study period

Eligibility criteria

Qualifiers

Patients ≥ 65 years

Successfully treated with percutaneous coronary intervention (PCI) with ≥ 1 drug-eluting stent (final TIMI 3 flow and visually estimated residual diameter stenosis <30%) for acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction and unstable angina) or chronic coronary syndrome (elective PCI). Inclusion is possible after the last PCI procedure in staged procedure.

Randomization must be performed before the discharge from the study site.

Written informed consent

Disqualifiers

PCI without drug-eluting stent implantation or with a bioresorbable scaffold

Planned coronary artery bypass grafting or cardiac surgery

Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period

Index PCI for stent thrombosis or chronic total occlusion

Trial design

Treatments tested in this trial

  • short dual antiplatelet therapy (DAPT) duration
  • Standard DAPT duration

Treatment groups

1,700 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vincent ROULE

Lead sponsor

University Hospital, Caen

Sponsor institution