[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649794":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":28,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":28,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":28,"enrollmentInfo":60,"targetDuration":28,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":78,"whyStopped":28,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Hadassah Medical Organization","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dipyridamole 75 mg twice daily (Day 1)","EXPERIMENTAL","Initial fixed dose-escalation step. All participants receive oral dipyridamole 75 mg twice daily on Day 1, with clinical monitoring for tolerability prior to escalation to the next dose level.",[13],"Drug: Dipyridamole 75 MG",{"label":15,"type":10,"description":16,"interventionNames":17},"Dipyridamole 75 mg three times daily (Day 2)","Second fixed dose-escalation step. Participants who tolerate the initial dose escalate to dipyridamole 75 mg three times daily on Day 2. The escalation schedule is fixed and identical for all participants; dosing is not individualized and accelerated escalation is not permitted.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Dipyridamole 75 mg four times daily (target dose, Day 3 onward)","Target maintenance dose. Participants escalate to dipyridamole 75 mg four times daily (300 mg\u002Fday total) from Day 3 onward, continuing throughout the antepartum period. Study drug is discontinued at least 12 hours before planned delivery, and at least 24 hours before planned delivery at which neuraxial anesthesia is anticipated. Temporary hold or de-escalation to a previously tolerated dose level is permitted based on adverse effects or investigator judgment.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Dipyridamole 75 MG","Oral dipyridamole 75 mg tablets, administered via a fixed structured dose escalation across the sequential arms described above (75 mg twice daily → three times daily → four times daily). The escalation schedule is identical for all participants; dosing is not individualized and accelerated escalation is not permitted.",[19,15,9],null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"Prof. Ofer Beharier, Principal Investigator","CONTACT","972+586306700","bofer@hadassah.org.il",[36],{"facility":37,"status":28,"city":38,"state":39,"zip":40,"country":39,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":28},"Hadassah University Medical Center","Jerusalem","Israel","9112001","IL",{"type":43,"coordinates":44},"Point",[45,46],35.21633,31.76904,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Bahrir Ofer","Prof. Ofer Beharier, MD, PhD Department of Obstetrics and Gynecology Hadassah University Medical Center, Jerusalem, Israel","100649794","phase-1-dipyridamole-for-early-onset-preeclampsia-a-pilot-study-of-feasibility-pharmacokinetics-and-biological-effects-100649794",false,"NCT07738562","Dipyridamole for Early-Onset Preeclampsia: A Pilot Study of Feasibility, Pharmacokinetics, and Biological Effects","* Age ≥ 18 years\n* Singleton pregnancy\n* Established early-onset preeclampsia, with or without severe features, with gestational age from 26+0 to 33+6 weeks at enrollment, confirmed by best obstetric estimate\n* Hospitalization for maternal and\u002For fetal surveillance\n* Expectant management deemed appropriate by the treating clinical team at the time of enrollment\n* sFlt-1\u002FPlGF ratio ≥85 at screening\n* Confirmed viable fetus without a known or suspected major structural or chromosomal anomaly\n* Baseline platelet count ≥100,000\u002FµL\n* Ability to provide written informed consent\n\nExclusion Criteria\n\n* Immediate indication for delivery at time of screening, including uncontrolled severe hypertension, eclampsia, HELLP syndrome, or severe fetal compromise\n* Active maternal bleeding or clinically significant bleeding disorder\n* Therapeutic-dose anticoagulation (e.g., enoxaparin \\>1 mg\u002Fkg\u002Fday)\n* Known hypersensitivity or contraindication to dipyridamole\n* Multiple gestation\n* Known major fetal anomaly or chromosomal abnormality\n* Baseline thrombocytopenia, platelet count \\\u003C100,000\u002FµL\n* Hemodynamically significant maternal cardiac disease\n* Significant maternal comorbidity that, in the investigator's judgment, precludes safe participation\n* Inability to comply with study procedures","FEMALE","18 Years",{"count":61,"type":62},15,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","Early-onset preeclampsia (PE), defined as preeclampsia presenting before 34 weeks of gestation, is a severe placental disorder associated with significant maternal and perinatal morbidity. There is currently no disease-modifying treatment; management relies on close surveillance and delivery, frequently resulting in extreme prematurity.\n\nRecent laboratory research identified ferroptosis, a form of iron-dependent regulated cell death driven by lipid peroxidation, as a key mechanism of placental injury in early-onset preeclampsia. A high-throughput drug screen identified dipyridamole, an approved oral antiplatelet and vasodilatory agent, as a potent ferroptosis inhibitor in primary human trophoblast cultures (EC50 = 0.146 µM), acting through mechanisms independent of its known phosphodiesterase-inhibitory pharmacology. In preeclamptic placental explants, dipyridamole markedly reduced release of sFlt-1, a central mediator of the maternal syndrome. Dipyridamole carries an established pregnancy safety record supported by randomized trials and a Cochrane meta-analysis of antiplatelet agents in pregnancy.\n\nThis is a prospective, single-center, open-label pilot study using a sequential, fixed dose-escalation design. The study will enroll 15 hospitalized pregnant women with early-onset preeclampsia (gestational age 26+0 to 33+6 weeks) and an elevated sFlt-1\u002FPlGF ratio (≥85), for whom expectant management is clinically appropriate. Enrollment proceeds through a staged sentinel design with safety gates reviewed by an independent Safety Monitoring Committee. Participants receive oral dipyridamole added to standard clinical care, using a fixed dose-escalation protocol (75 mg twice daily on Day 1, escalating over 2-3 days to a target dose of 75 mg four times daily, 300 mg\u002Fday total). Standard obstetric care continues unchanged, determined entirely on clinical grounds, independent of study participation.\n\nThe primary objective is to evaluate the feasibility and clinical implementability of the dipyridamole treatment protocol within routine inpatient obstetric care. Secondary objectives include characterizing the pharmacokinetics of dipyridamole during pregnancy, assessing tolerability, and evaluating longitudinal circulating angiogenic biomarkers (sFlt-1 and PlGF). Exploratory objectives include assessment of placental markers of oxidative stress and ferroptosis-related pathways in tissue obtained at delivery.\n\nStudy drug is administered during the antepartum period only and discontinued before delivery. This pilot study is not designed to establish clinical efficacy, but to provide the pharmacokinetic, tolerability, and biological data required to design a subsequent randomized trial.",[69,70],"Preeclampsia (PE)","Hypertension ,Pregnancy",[72,73,74,75,76,77],"Preeclampsia treatment","preeclampsia management","treating mild preeclampsia","Early-onset preeclampsia","hypertensive pregnancy disease","preeclampsia disease-modifying therapy","NOT_YET_RECRUITING","2026-07-27",{"date":81,"type":82},"2026-07-31","ACTUAL",{"date":84,"type":62},"2026-09",{"date":86,"type":62},"2028-09",{"name":5,"class":6},1]