Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT07164859
Eligibility Criteria:
Inclusion Criteria:
* 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
* Social security affiliated
Exclusion Criteria:
* 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
* Patients with uncorrected severe hearing or visual handicap
* Patients with addictive alcohol, drug or substance abuse
* Patients with protective measures (guardianship, tutorship, curatorship)
* Any other condition considered by the investigators as not warranting informed consent
* patients with poor quality of the downstream territory with diffuse distal coronary disease
* women of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hysterectomy, bilateral salpingectomy or bilateral oophorectomy-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07164859
Study Brief:
Protocol Section:
NCT07164859