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

NCT07164859 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1700

Last updated 2025-10-01

No results posted yet for this study

Summary

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

Conditions

  • Coronary Artery Disease (CAD)
  • Percutaneous Coronary Intervention (PCI)
  • Antiplatelet Therapy
  • Elderly (People Aged 65 or More)

Interventions

DRUG

short dual antiplatelet therapy (DAPT) duration

patients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone

DRUG

Standard DAPT duration

patients will receive DAPT for at least 3 months after randomization or longer and followed by single antiplatelet therapy

Sponsors & Collaborators

  • Vincent ROULE

    lead OTHER

Principal Investigators

  • Vincent ROULE, MD, PhD · University Hospital, Caen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2029-10-31
Completion
2029-10-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07164859 on ClinicalTrials.gov