Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-27 @ 4:15 PM
Study NCT ID:
NCT06168461
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2023-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Daily Aspirin Treatment After Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2023-09-13', 'studyFirstSubmitQcDate': '2023-12-04', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'magnitude of microvascular endothelial function', 'timeFrame': 'baseline, 12 weeks', 'description': 'skin blood flow response to acetylcholine delivered via intradermal microdialysis'}, {'measure': 'magnitude of brachial artery endothelial function', 'timeFrame': 'baseline, 12 weeks', 'description': 'brachial artery flow mediated dilation'}, {'measure': 'magnitude of microvascular endothelin-1 mediated constriction', 'timeFrame': 'baseline, 12 weeks', 'description': 'skin blood flow response to endothelin-1 delivered via intradermal microdialysis'}], 'secondaryOutcomes': [{'measure': 'magnitude of microvascular nitric oxide-dependent dilation', 'timeFrame': 'baseline, 12 weeks', 'description': 'skin blood flow response to acetylcholine + L-NAME delivered via intradermal microdialysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preeclampsia'], 'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'Women who develop preeclampsia during pregnancy are four times more likely to develop cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs may be related to lasting blood vessel damage after the pregnancy but there are currently no specific treatment strategies to prevent this disease progression. This study addresses this public health issue by examining whether starting low dose aspirin therapy after pregnancy is an effective treatment for lasting blood vessel damage in order to inform better clinical management of cardiovascular disease risk in women who have had preeclampsia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* had preeclampsia in the past 5 years,\n* 18 years or older\n\nExclusion criteria:\n\n* current daily aspirin use,\n* skin diseases,\n* current tobacco or nicotine use (including vaping),\n* diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \\< 60 mL/min/1.73m2,\n* statin or other cholesterol-lowering medication,\n* current antihypertensive medication,\n* history of hypertension prior to pregnancy,\n* history of gestational diabetes,\n* currently pregnancy,\n* body mass index \\<18.5 kg/m2,\n* allergy to materials used during the experiment.(e.g. latex),\n* known allergies to study drugs,\n* bleeding disorders, peptic ulcer disease, gastritis, GI bleeding and gastroesophageal reflux disease (GERD).'}, 'identificationModule': {'nctId': 'NCT06168461', 'briefTitle': 'Daily Aspirin Treatment After Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Aspirin for the Treatment of Vascular Dysfunction After Preeclampsia', 'orgStudyIdInfo': {'id': '202303799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'placebo pill taken once daily at bedtime for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'aspirin', 'description': '162mg aspirin taken once daily at bedtime for 12 weeks', 'interventionNames': ['Drug: Aspirin']}], 'interventions': [{'name': 'Aspirin', 'type': 'DRUG', 'description': '162mg aspirin capsule', 'armGroupLabels': ['aspirin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo capsule', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anna Stanhewicz', 'role': 'CONTACT', 'email': 'anna-stanhewicz@uiowa.edu', 'phone': '319-467-1732'}], 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'centralContacts': [{'name': 'Anna Reid-Stanhewicz, PHD', 'role': 'CONTACT', 'email': 'anna-stanhewicz@uiowa.edu', 'phone': '319-467-1732'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anna Stanhewicz, PhD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Anna Stanhewicz, PhD', 'investigatorAffiliation': 'University of Iowa'}}}}