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

NCT07164859 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 2023-507545-28-00
• Study Type: interventional
• Target: 1,700
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

antiplatelet therapy; percutaneous coronary intervention; elderly

Outcome Measures

Primary Outcomes (1)

• net clinical benefit

  composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5

  12 months after randomization

Secondary Outcomes (4)

• Major or clinically relevant non-major bleeding

  12 months

• Major or clinically relevant non-major bleeding

  12 months

• Major cardiovascular and cerebrovascular events

  12 months

• Major bleeding (BARC 3 or 5)

  12 months

Other Outcomes (9)

• net clinical benefit

  12 months

• all-cause death

  12 months

• myocardial infarction

  12 months

Study Arms (2)

standard DAPT duration

ACTIVE 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)

Drug: Standard DAPT duration

short DAPT

EXPERIMENTAL

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

Drug: short dual antiplatelet therapy (DAPT) duration

Interventions

short dual antiplatelet therapy (DAPT) duration DRUG

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

short DAPT

Standard DAPT duration DRUG

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

standard DAPT duration

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients ≥ 65 years
• Randomization must be performed before the discharge from the study site.
• Written informed consent
• Social security affiliated

You may not qualify if:

• 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
• Need for oral anticoagulation therapy
• Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel
• Use of fibrinolytic therapy within 24 hours of PCI
• Severe renal insufficiency (MDRD creatinine clearance \< 30 ml/min/m2) and/or dialysis
• Increased bleeding risk (prior hemorrhagic stroke; stroke \< 30 days; brain injury\<6 months; history of intracranial tumor or intracranial hemorrhage; internal bleeding\<6 weeks; active bleeding; anemia (hemoglobin ≤ 8 g/dl) or thrombocytopenia (platelets \< 100 000 G/L); major surgery\<3 weeks)
• increased thrombotic risk related to the patient (previous stent thrombosis, ≥ 2 previous myocardial infarction, symptomatic peripheral artery disease, chronic systemic inflammatory disease treated with corticoids or immunosuppressive drug) or the procedure (left main treated, ≥3 stents/treated lesions, total length of stents\>60mm, bifurcation lesion with stents in each branch, stenting of the last patent vessel)
• Life expectancy less than 1 year
• Participation in another interventional trial
• Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:
• Patients with known or discovered severe cognitive impairment
• Patients with treated or untreated severe psychological or psychiatric conditions

Sponsors & Collaborators

• Vincent ROULE: lead

Study Sites (1)

Caen University Hospital

Caen, 14000, France

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine; Time

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Vincent ROULE, MD, PhD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent ROULE, MD, PhD

CONTACT

+33231063975; roule-v@chu-caen.fr

Elsa LE BLANC, PhD

CONTACT

+33231065135; leblanc-e@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)