Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-02 @ 1:48 PM
Study NCT ID:
NCT07164859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2025-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028145', 'term': "2'-deoxythymidylyl-(3'-5')-2'-deoxyadenosine"}, {'id': 'D013995', 'term': 'Time'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, open label, blinded endpoint assessment, randomized non-inferiority trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1700}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'net clinical benefit', 'timeFrame': '12 months', 'description': 'a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined as BARC grade 3 or 5, evaluated as superior or not'}, {'measure': 'all-cause death', 'timeFrame': '12 months'}, {'measure': 'myocardial infarction', 'timeFrame': '12 months', 'description': 'myocardial infarction type 1, 3 or 4b based on the universal definition'}, {'measure': 'Any stroke', 'timeFrame': '12 months', 'description': 'Any stroke rates, defined by NeuroARC types 1.a, .b, .c, .d or 1.a.H or 3.a'}, {'measure': 'Intracranial bleeding', 'timeFrame': '12 months', 'description': 'Intracranial bleeding rates defined by NeuroARC type 1.a.H, 1.b, 1.c hemorrhagic CNS injury'}, {'measure': 'cardiovascular death', 'timeFrame': '12 months', 'description': 'Death of cardiovascular cause (according to ARC-2 definition)'}, {'measure': 'stent thrombosis', 'timeFrame': '12 months', 'description': 'stent thrombosis rates (definite or probable, ARC-2 definition)'}, {'measure': 'All-cause hospitalization', 'timeFrame': '12 months', 'description': 'hospitalization for any cause, lasting ≥ 24h from the admission to the hospital'}, {'measure': 'Urgent/unplanned symptoms-driven coronary revascularization', 'timeFrame': '12 months', 'description': 'Unstable angina leading to coronary revascularization (with percutaneous coronary intervention or coronary artery bypass grafting)'}], 'primaryOutcomes': [{'measure': 'net clinical benefit', 'timeFrame': '12 months after randomization', 'description': 'composite of all-cause death, myocardial infarction, stroke and major bleeding BARC 3 or 5'}], 'secondaryOutcomes': [{'measure': 'Major or clinically relevant non-major bleeding', 'timeFrame': '12 months', 'description': 'Major or clinically relevant non-major bleeding (BARC 2, 3 or 5), non inferiority of the experimental arm tested'}, {'measure': 'Major or clinically relevant non-major bleeding', 'timeFrame': '12 months', 'description': 'Major or clinically relevant non-major bleeding (BARC 2, 3 or 5), superiority of the experimental arm tested'}, {'measure': 'Major cardiovascular and cerebrovascular events', 'timeFrame': '12 months', 'description': 'a composite of all-cause death, myocardial infarction and stroke, non inferiority of the experimental arm tested'}, {'measure': 'Major bleeding (BARC 3 or 5)', 'timeFrame': '12 months', 'description': 'Major bleeding (BARC 3 or 5), superiority of the experimental arm tested'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['antiplatelet therapy', 'percutaneous coronary intervention', 'elderly'], 'conditions': ['Coronary Artery Disease (CAD)', 'Percutaneous Coronary Intervention (PCI)', 'Antiplatelet Therapy', 'Elderly (People Aged 65 or More)']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions it aims to answer are:\n\nDoes 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.\n\nParticipants will:\n\n* Take aspirin for 7 days in one group or 3 to 12 months in another group\n* Be contacted by phone at 7 days, 14 days, 21 days, 30 days, 3 months, 6 months and 12 months after hospital discharge\n* Keep a diary of any bleeding or cardiovascular events occurring during the study period', 'detailedDescription': 'While dual antiplatelet therapy (DAPT) is the cornerstone of medical therapy after percutaneous coronary intervention (PCI), its optimal duration is still under debate. DAPT reduces the incidence of thrombotic events but exposes patients to an increased risk of bleeding strongly associated with mortality. Older age is a known predictor of bleeding risk. In the elderly, the duration of DAPT appears to be the most relevant modifiable risk factor.\n\nBleeding consequences triggered investigations into a further reduction in DAPT duration with the use of the newer generation drug-eluting stent (DES) but none specifically focused on elderly patients. Single antiplatelet therapy (SAPT) using a P2Y12 inhibitor after a short period of DAPT (between 1 and 3 months) has been recently tested in some studies. A meta-analysis focusing on the elderly subgroups (with cut-offs ranging between 65 and 75 years-old) showed similar rates of major bleeding and the composite ischemic endpoint but with a high level of heterogeneity highlighting the need of specific studies in this particular population. A recent large study, including a large proportion of patients ≥ 75 years and comparing SAPT after 1 month of DAPT to DAPT ≥ 3 months, showed a lower incidence of major bleedings while net adverse clinical events and major adverse cardiac events remain non-inferior. In the presence of strong P2Y12 receptor blockade, aspirin provides little additional inhibition of platelet aggregation and inhibition of hemostatic system activation has been reported to be comparable between P2Y12 inhibitor monotherapy and DAPT in healthy subjects. The low thrombogenicity of new coronary devices, potent platelet inhibition with new P2Y12 inhibitors in monotherapy and the potential life-threatening consequences of bleeding which occur mostly in the weeks following PCI support the idea of very short DAPT after PCI in elderly.\n\nThe investigators propose a multi-center randomized study to compare the safety and efficacy of very short versus standard-duration DAPT after PCI with DES in elderly patients. The investigators aim to determine whether short DAPT (for 7 days after randomization) followed by SAPT with P2Y12 inhibitor is non inferior to standard-duration DAPT regarding net clinical benefit (a composite of all-cause death, myocardial infarction, stroke, and major bleeding defined by Bleeding Academic Research Consortium (BARC) 3 or 5) at 1 year in elderly patients undergoing PCI for acute or chronic coronary syndrome.\n\nThe investigators hypothesized that the very short strategy will be non-inferior to the standard-duration strategy. The very short strategy may allow to further reduce bleedings while maintaining the ischemic risk and may consequently become the default strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥ 65 years\n* 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.\n* Randomization must be performed before the discharge from the study site.\n* Written informed consent\n* Social security affiliated\n\nExclusion Criteria:\n\n* PCI without drug-eluting stent implantation or with a bioresorbable scaffold\n* Planned coronary artery bypass grafting or cardiac surgery\n* Any planned surgery within 12 months unless intended antiplatelet therapy could be maintained throughout the peri-surgical period\n* Index PCI for stent thrombosis or chronic total occlusion\n* Need for oral anticoagulation therapy\n* Known hypersensitivity or allergy to aspirin, clopidogrel, ticagrelor or prasugrel\n* Use of fibrinolytic therapy within 24 hours of PCI\n* Severe renal insufficiency (MDRD creatinine clearance \\< 30 ml/min/m2) and/or dialysis\n* 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)\n* 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)\n* Life expectancy less than 1 year\n* Participation in another interventional trial\n* Patients considered as vulnerable by the investigators because of medical, psychological or social conditions:\n\n * Patients with known or discovered severe cognitive impairment\n * Patients with treated or untreated severe psychological or psychiatric conditions\n * Patients with uncorrected severe hearing or visual handicap\n * Patients with addictive alcohol, drug or substance abuse\n * Patients with protective measures (guardianship, tutorship, curatorship)\n * Any other condition considered by the investigators as not warranting informed consent\n* patients with poor quality of the downstream territory with diffuse distal coronary disease\n* 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-'}, 'identificationModule': {'nctId': 'NCT07164859', 'acronym': 'SOLOPCI', 'briefTitle': 'Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Safety and Efficacy of Very Short Dual Antiplatelet Therapy Followed by P2Y12 Inhibitor Monotherapy in Older Patients Undergoing Percutaneous Coronary Intervention (SOLOPCI)', 'orgStudyIdInfo': {'id': '2023-507545-28-00'}, 'secondaryIdInfos': [{'id': '2023-507545-28-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard DAPT duration', 'description': '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)', 'interventionNames': ['Drug: Standard DAPT duration']}, {'type': 'EXPERIMENTAL', 'label': 'short DAPT', 'description': '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', 'interventionNames': ['Drug: short dual antiplatelet therapy (DAPT) duration']}], 'interventions': [{'name': 'short dual antiplatelet therapy (DAPT) duration', 'type': 'DRUG', 'description': 'patients will receive DAPT for 7 days (after randomization) followed by P2Y12 inhibitor alone', 'armGroupLabels': ['short DAPT']}, {'name': 'Standard DAPT duration', 'type': 'DRUG', 'description': 'patients will receive DAPT for at least 3 months after randomization or longer and followed by single antiplatelet therapy', 'armGroupLabels': ['standard DAPT duration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Vincent ROULE, MD, PhD', 'role': 'CONTACT', 'email': 'roule-v@chu-caen.fr', 'phone': '+33231063975'}, {'name': 'Vincent ROULE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}], 'centralContacts': [{'name': 'Vincent ROULE, MD, PhD', 'role': 'CONTACT', 'email': 'roule-v@chu-caen.fr', 'phone': '+33231063975'}, {'name': 'Elsa LE BLANC, PhD', 'role': 'CONTACT', 'email': 'leblanc-e@chu-caen.fr', 'phone': '+33231065135'}], 'overallOfficials': [{'name': 'Vincent ROULE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Caen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vincent ROULE', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Vincent ROULE', 'investigatorAffiliation': 'University Hospital, Caen'}}}}