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NOT YET RECRUITING

NCT07164859

PHASE3

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

Sponsor: Vincent ROULE

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1700

Start Date

2025-10

Completion Date

2029-10

Last Updated

2025-10-01

Healthy Volunteers

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

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-

Locations (1)

Caen University Hospital

Caen, France