Shorter Blood-Thinner Course After Heart Stenting in Older Adults

Trial details

Who runs it

Vincent ROULE

Trial code

NCT07164859EU 2023-507545-28-00

Record updated

3 November 2026

Original description

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.Read full original descriptionShow less

Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)

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

Inclusion: 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: PCI without drug-eluting stent implantation or with a bioresorbable scaffold; Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period; Need for oral anticoagulation therapy; Use of fibrinolytic therapy within 24 hours of PCI; 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 index clinical event (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); Planned coronary artery bypass grafting or cardiac surgery; Index clinical event PCI for stent thrombosis, in-stent restenosis or chronic total occlusion; Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel; 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; 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); Life expectancy less than 1 year; Participation in another interventional trial; 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-.

ClinicalTrials.gov NCT07164859 · EU CTIS 2023-507545-28-00