Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-25 @ 2:43 PM
Study NCT ID:
NCT04295850
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2020-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum samples collected prospectively prior to aspirin initiation, after aspirin initation, and in the third trimester'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aim 1: PFA-100 closure time and risk of hypertensive disorder of pregnancy (HDP)', 'timeFrame': '8 months (delivery)', 'description': 'Difference in first trimester PFA-100 closure time between patients started on aspirin who do and do not develop HDP'}, {'measure': 'Aim 2: Pharmacogenomics of aspirin', 'timeFrame': '2 weeks', 'description': 'Difference in PFA-100 closure time with aspirin therapy based on platelet receptor genotype'}, {'measure': 'Aim 3: MicroRNAs and HDP', 'timeFrame': '8 months (delivery)', 'description': 'Regression analysis to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels in first trimester are associated with risk of HDP'}, {'measure': 'Aim 4: Aspirin pharmacokinetics in pregnancy', 'timeFrame': '2 weeks', 'description': 'Define population based pharmacokinetic model of aspirin in first trimester of pregnancy taking into consideration individual factors (gestational age, race, BMI, genotype)'}], 'secondaryOutcomes': [{'measure': 'Aim 1: Aspirin response', 'timeFrame': '2 weeks', 'description': 'Multiple logisitic regression analysis to evaluate factors (BMI, race, gestational age, genotype) associated with rate of nonresponse to aspirin therapy defined as (PFA-100\\>150s)'}, {'measure': 'Aim 1: Prediction of HDP', 'timeFrame': '8 months (delivery)', 'description': 'ROCC curve to determine threshold PFA-100 closure time after 1 week of aspirin therapy that is predictive of HDP'}, {'measure': 'Aim 1: First trimester serum thromboxane and risk of HDP', 'timeFrame': '8 months (delivery)', 'description': 'Comparison between first trimester serum thromboxane in those with and without hypertensive disorder of pregnancy'}, {'measure': 'Aim 1: Third trimester serum thromboxane and risk of HDP', 'timeFrame': '8 months (delivery)', 'description': 'Comparison between third trimester serum thromboxane in those with and without hypertensive disorder of pregnancy'}, {'measure': 'Aim 2: Pharmacogenomics and Pregnancy outcome', 'timeFrame': '8 months (delivery)', 'description': 'Multiple regression analysis taking into consideration platelet receptor genotype, race, BMI, and other clinical characteristics and prediction of HDP'}, {'measure': 'Aim 3: MicroRNA profile and aspirin therapy', 'timeFrame': '2 weeks', 'description': 'Paired comparison to evaluate how miRNAs 223, 126, 155, 181a, 18a, 16 levels change before and after aspirin therapy'}, {'measure': 'Aim 4: Salicylic acid level and Serum Thromboxane', 'timeFrame': '2 weeks', 'description': 'Association between serum salicylic acid with aspirin therapy and serum thromboxane with aspirin therapy'}, {'measure': 'Predictors of preterm birth', 'timeFrame': '8 months (delivery)', 'description': 'Multivariable logistic regression to evaluate markers predictive of preterm birth'}, {'measure': 'Predictors of preeclampsia', 'timeFrame': '8 months (delivery)', 'description': 'Multivariable logistic regression to evaluate markers predictive of preeclampsia and preterm preeclampsia'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'descriptionModule': {'briefSummary': 'This proposal has three aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of hypertensive disorders of pregnancy (HDP) through a prospective, cohort study using pharmacokinetics, pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.', 'detailedDescription': 'This proposal has four aims to characterize the relationship between aspirin therapy, platelet function response, and prevention of HDP through a prospective, cohort study using pharmacodynamics, pharmacogenomics and bioinformatics. The results of this proposal will provide necessary data for prospective study on individualized aspirin dose adjustment for prevention of HDP.\n\nAim 1: Establish pharmacodynamic endpoints for aspirin in prevention of HDP Hypothesis: PFA-100 closure time and serum thromboxane/urinary dehydrothromboxane-B2 (dTX-B2) are pharmacodynamic markers of aspirin response and are predictive of HDP high risk pregnant patients.\n\nAim 2: Explore aspirin pharmacogenetics by assessing the relationship between platelet receptor genotype, aspirin response, and prevention of HDP Hypothesis: Platelet receptor genotype is associated with race and may result in reduced platelet response to aspirin therapy, and increased incidence of HDP.\n\nAim 3: Assess the utility of circulating microRNA as a marker of aspirin response in pregnancy and risk of HDP Hypothesis: Quantitative expression of selected miRNAs are biomarkers for response to aspirin therapy and risk of HDP.\n\nAim 4: Evaluate aspirin pharmacokinetics/pharmacodynamics Hypothesis: Individual factors influence aspirin pharmacokinetics/pharmacodynamics and may impact individual dosing of aspirin'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients at high risk for preeclampsia', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Pregnant singleton, \\<16 weeks' gestation\n* At least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, chronic kidney disease, lupus, antiphospholipid antibody syndrome\n\nExclusion Criteria:\n\n* Contraindication to aspirin\n* Current or planned use of any other anticoagulation\n* Use of aspirin in pregnancy prior to enrollment\n* Known platelet disorder at time of enrollment"}, 'identificationModule': {'nctId': 'NCT04295850', 'acronym': 'APROACH', 'briefTitle': 'Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Antenatal Platelet Response On Aspirin and Correlation With HDP (Hypertensive Disorders of Pregnancy)', 'orgStudyIdInfo': {'id': '19F.887'}, 'secondaryIdInfos': [{'id': 'R21HD101127', 'link': 'https://reporter.nih.gov/quickSearch/R21HD101127', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low Dose Aspirin', 'description': "Pregnant singletons at high risk for preeclampsia based on:\n\n* at least one high risk factor for preeclampsia: prior preeclampsia, chronic hypertension, pregestational diabetes, lupus, antiphospholipid antibody syndrome, or chronic kidney disease. OR\n* at least two of the following: BMI\\>30, black race, state insurance, IVF pregnancy, advanced maternal age, nulliparous or \\>10yr from last delivery, prior adverse pregnancy outcome\n\nwho are planning to, but have not yet started, aspirin therapy \\<16 weeks' gestation. Patients will take 81mg aspirin as prescribed.", 'interventionNames': ['Drug: Aspirin 81 mg']}], 'interventions': [{'name': 'Aspirin 81 mg', 'type': 'DRUG', 'description': 'Aspirin 81mg daily PO', 'armGroupLabels': ['Low Dose Aspirin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD may be shared upon individual request after publication of planned analyses'}, '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'}}}}