Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-28 @ 1:45 PM
Study NCT ID:
NCT04645004
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2020-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy
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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One arm PK/PD study of aspirin in pregnancy1'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-17', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-19', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'salicylic acid level', 'timeFrame': '24 hour', 'description': 'time/concentration profile'}, {'measure': 'serum thromboxane', 'timeFrame': '4 week post initiation', 'description': 'ELISA based quantification of serum thromboxane B2'}, {'measure': 'PFA-100', 'timeFrame': '4 week post initiation', 'description': 'PFA-100 epi closure time (Siemens)'}], 'secondaryOutcomes': [{'measure': 'Urinary thromboxane', 'timeFrame': '4 week post initiation', 'description': 'ELISA based quantification of urindary dehydrothromboxane B2'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'Longitudinal pharmacokinetic and pharmacodynamic study in first and third trimester of pregnancy', 'detailedDescription': 'This will be a longitudinal addition to an existing R21cohort enrolled in the first trimester to include a first and third trimester assessment of pharmacokinetics/pharmacodynamics (PK/PD) of aspirin and how individual factors impact aspirin PK/PD in pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* \\<16 weeks' gestational age\n* Singleton pregnancy\n* Plan to take 81mg aspirin due to high risk history (below), but not yet initiated\n* ≥1 risk factor:\n\n * Chronic hypertension\n * Type I or II diabetes\n * Previous preeclampsia\n * Renal disease\n * Autoimmune disease (SLE) OR\n\n ≥2 risk factor:\n * Nulliparity\n * IVF pregnancy\n * Black race or socioeconomic disadvantaged\n * BMI\\>30\n * Prior adverse pregnancy outcome\n\nExclusion Criteria:\n\n* Contraindication to aspirin\n* Current or planned use of any other anticoagulation\n* Current need for dialysis\n* Use of aspirin therapy prior to enrollment in the current pregnancy\n* Thrombocytopenia (\\<150)\n* Other known platelet disorder/thrombophilia at enrollment"}, 'identificationModule': {'nctId': 'NCT04645004', 'acronym': 'APROACH-PK', 'briefTitle': 'Antenatal Platelet Response on Aspirin: a Pharmacokinetic Study Through Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Impact of Maternal Aspirin Tehrapy on the Maternal/Fetal Unit at Delivery: a Study of Aspirin Pharmacokinetics, Pharmacodynamics, and Pharmacogenomics Through Pregnancy', 'orgStudyIdInfo': {'id': '20F.911'}, 'secondaryIdInfos': [{'id': '3R21HD101127-01S1', 'link': 'https://reporter.nih.gov/quickSearch/3R21HD101127-01S1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Aspirin', 'description': '81mg aspirin daily', 'interventionNames': ['Drug: Aspirin 81Mg Non-enteric coated Tab']}], 'interventions': [{'name': 'Aspirin 81Mg Non-enteric coated Tab', 'type': 'DRUG', 'description': 'one tab daily', 'armGroupLabels': ['Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Rupsa C Boelig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Following publication of data, 12 months following study completion', 'ipdSharing': 'YES', 'description': 'Final results of this study will plan to be submitted for publication within 12 months of completion of analysis of samples. Following publication, a data set excluding any protected health information will be available on request pending agreement on use of data and appropriate IRB approval for data sharing agreement with the outside individuals or institutions requesting data. The data sharing agreement will provide that the individual/institution requesting the data will commit to using the data only for research purposes and not attempt to identify any individual participant, to secure the data using appropriate computer technology and security, and finally to destroy or return the data set after analyses are completed.', 'accessCriteria': 'The data sharing agreement will provide that the individual/institution requesting the data will commit to using the data only for research purposes and not attempt to identify any individual participant, to secure the data using appropriate computer technology and security, and finally to destroy or return the data set after analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'March of Dimes', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}