Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-25 @ 3:15 PM
Study NCT ID:
NCT06165068
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}, {'id': 'D000111', 'term': 'Acetylcysteine'}], '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'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 153347, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-12-01T00:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1. Aspirin 81 mg/d or Clopidogrel 75 mg/d\n2. Aspirin 81 mg/d or Clopidogrel 75 mg/d with N-acetylcysteine 600 mg/d\n3. No medication'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-12-01', 'studyFirstSubmitQcDate': '2023-12-01', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drusen volume analysis', 'timeFrame': '1 year', 'description': 'To assess AMD progression in patient with large drusen, drusen volume was measured and analyzed in each patient group by OCT scan'}], 'secondaryOutcomes': [{'measure': 'Best-corrected visual acuity change', 'timeFrame': '1 year', 'description': 'To evaluate Best-corrected visual acuity in each patient group by ETDRS chart'}, {'measure': 'Rate of disease progression', 'timeFrame': '1 year', 'description': 'To evaluate disease progression to geographic atrophy or neovascular AMD by OCT scan and fundus photo'}, {'measure': 'Side effects of medications intake', 'timeFrame': '1 year', 'description': 'To evaluate the safety of the medication used by questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to evaluate the effect of low doses of antiplatelet medications (aspirin 81 mg/day or clopidogrel 75 mg/day) with or without a combination of antioxidants (N-acetylcysteine 600 mg/day) in a dry AMD patient with large drusen.\n\nParticipants will divided in to three groups.\n\n* Participants who were already taking low dose antiplatelet medications.\n* Participants who take the antiplatelet drug mentioned above in addition to the antioxidant prescribed by the investigator\n* Participants does not use any medications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry AMD with at least 1 large drusen. According to the AREDS study, large drusen have a size of more than 125 micron.\n* Patients can evaluate SD-OCT (Spectral domain optical coherence tomography), OCT angiography, and best-corrected visual acuity.\n* Age range: 50-85 years\n* Patients who have previously used antiplatelet drugs.\n\nExclusion Criteria:\n\n* Patient with advanced AMD, such as geographic atrophy, neovascular complications (choroidal neovascularization)\n* Patient with additional retinal diseases that affect visual acuity, e.g., retinal detachment, diabetic macular edema.\n* Patient with a history of intravitreal anti-VEGF injection or macular laser.\n* Patient using SSRIs, SNRIs, azole, NSAIDs, dual antiplatelet, anticoagulant medications.'}, 'identificationModule': {'nctId': 'NCT06165068', 'briefTitle': 'Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Navamindradhiraj University'}, 'officialTitle': 'Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study', 'orgStudyIdInfo': {'id': '193/65 FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Antiplatelet drug', 'description': 'In this study, antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day.', 'interventionNames': ['Drug: Aspirin 81Mg Ec Tab', 'Drug: Clopidogrel']}, {'type': 'EXPERIMENTAL', 'label': 'Antiplatelet drug with antioxidant', 'description': 'Antiplatelet drugs are medications that patients take to treat their underlying condition, such as aspirin 81 mg/day or clopidogrel 75 mg/day combined with N-acetylcysteine 600 mg/day.', 'interventionNames': ['Drug: Aspirin 81Mg Ec Tab', 'Drug: Clopidogrel', 'Drug: N-acetylcysteine']}, {'type': 'NO_INTERVENTION', 'label': 'No medication', 'description': 'Patient with no medication used.'}], 'interventions': [{'name': 'Aspirin 81Mg Ec Tab', 'type': 'DRUG', 'description': 'Patients take aspirin 81 mg per day.', 'armGroupLabels': ['Antiplatelet drug', 'Antiplatelet drug with antioxidant']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': 'Patients take clopidogrel 75 mg per day.', 'armGroupLabels': ['Antiplatelet drug', 'Antiplatelet drug with antioxidant']}, {'name': 'N-acetylcysteine', 'type': 'DRUG', 'otherNames': ['NAC-long'], 'description': 'Patients are given N-acetylcysteine 600 mg per day.', 'armGroupLabels': ['Antiplatelet drug with antioxidant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10300', 'city': 'Bangkok', 'state': 'Dusit', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Yolradee Winuntamalakul', 'role': 'CONTACT', 'email': 'yolradee.win@nmu.ac.th', 'phone': '+6622443874'}], 'facility': 'Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Yolradee Winuntamalakul', 'role': 'CONTACT', 'email': 'yolradee.win@nmu.ac.th', 'phone': '+66851283362'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Navamindradhiraj University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yolradee Winuntamalakul', 'investigatorAffiliation': 'Navamindradhiraj University'}}}}