Effects of Antiplatelet and Antioxidant Agents on Drusen Progression: A Pilot, Prospective Cohort Study
NCT ID: NCT06165068
Last Updated: 2023-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
174 participants
INTERVENTIONAL
2023-12-31
2026-09-30
Brief Summary
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Participants will divided in to three groups.
* Participants who were already taking low dose antiplatelet medications.
* Participants who take the antiplatelet drug mentioned above in addition to the antioxidant prescribed by the investigator
* Participants does not use any medications.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
2. Aspirin 81 mg/d or Clopidogrel 75 mg/d with N-acetylcysteine 600 mg/d
3. No medication
PREVENTION
NONE
Study Groups
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Antiplatelet drug
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.
Aspirin 81Mg Ec Tab
Patients take aspirin 81 mg per day.
Clopidogrel
Patients take clopidogrel 75 mg per day.
Antiplatelet drug with antioxidant
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.
Aspirin 81Mg Ec Tab
Patients take aspirin 81 mg per day.
Clopidogrel
Patients take clopidogrel 75 mg per day.
N-acetylcysteine
Patients are given N-acetylcysteine 600 mg per day.
No medication
Patient with no medication used.
No interventions assigned to this group
Interventions
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Aspirin 81Mg Ec Tab
Patients take aspirin 81 mg per day.
Clopidogrel
Patients take clopidogrel 75 mg per day.
N-acetylcysteine
Patients are given N-acetylcysteine 600 mg per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients can evaluate SD-OCT (Spectral domain optical coherence tomography), OCT angiography, and best-corrected visual acuity.
* Age range: 50-85 years
* Patients who have previously used antiplatelet drugs.
Exclusion Criteria
* Patient with additional retinal diseases that affect visual acuity, e.g., retinal detachment, diabetic macular edema.
* Patient with a history of intravitreal anti-VEGF injection or macular laser.
* Patient using SSRIs, SNRIs, azole, NSAIDs, dual antiplatelet, anticoagulant medications.
50 Years
85 Years
ALL
No
Sponsors
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Navamindradhiraj University
OTHER
Responsible Party
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Yolradee Winuntamalakul
Principal Investigator
Locations
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Department of ophthalmology, Faculty of medicine, Vajira hospital, Navamindradhiraj University
Bangkok, Dusit, Thailand
Countries
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Central Contacts
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Facility Contacts
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Yolradee Winuntamalakul
Role: primary
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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193/65 FB
Identifier Type: -
Identifier Source: org_study_id