NCT05287321 The Efficacy of Aspirin Combined With Hydroxychloroquine Treatment in High Risk Pregnancies for Preeclampsia
| NCT ID | NCT05287321 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yoo-min Kim |
| Condition | Preeclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 58 participants |
| Start Date | 2022-05-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 58 participants in total. It began in 2022-05-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is prospective, single arm group ,open label, and multicenter trial (with two parallel-group \[Hydroxychloroquine 200mg with Aspirin 100mg or Aspirin 100mg\])
Eligibility Criteria
Inclusion Criteria: 1. The singleton pregnant women aged from 19 to 50 years 2. Includes at least one factors of the below ① History of preeclampsia ② History of fetal growth restriction ③ History of intrauterine fetal death 3. Women who have agreed to enroll in the study and given their informed consent Exclusion Criteria: 1. Indication to a treatment according to the severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychiatric, infectious disease and malignancy (However, the participation of the trial is allowed by the investigator based on medically necessary.) 2. Previous inclusion in other intervention study within 3 months of screening (except for non-interventional observational studies) 3. Major malformation of the fetus is diagnosed at 11-13 weeks of gestation 4. Elevated blood concentrations of creatinine more than double the normal value 5. Elevated blood concentrations of liver transaminases (AST(GOT) or ALT(GPT)) more than three times the normal value 6. Conditions related with aspirin treatment * Previous exposure within 28 days of screening * Previous NSAID exposure within 28 days of screening * Bleeding disorder (von Willebrand's disease, peptic ulceration) * Hypersensitivity to aspirin 7. Conditions related with hydroxychloroquine treatment * Previous exposure within 28 days of screening * Hypersensitivity to hydroxychloroquine and 4-aminoquinoline compounds * Maculopathy * Medications that has potential for visual disturbance * Women who have potential for changes in the retina or visual impairment by 4-aminoquinoline compounds * Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption * Prolonged QT interval on EKG (congenital or acquired) or The risk factors of QT prolongation (heart failure, arrhythmia, myocardial ischemia) * Low level of potassium in the blood * Low level of magnesium in the blood 8. Not suitable for participant based on medical evidence by investigator
Contact & Investigator
Yoo-min Kim, MD
PRINCIPAL INVESTIGATOR
Chung-Ang University Gwangmyeong Hospital
Frequently Asked Questions
Who can join the NCT05287321 clinical trial?
This trial is open to female participants only, aged 19 Years or older, up to 50 Years, studying Preeclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05287321 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 58 participants.
Is NCT05287321 currently recruiting?
Yes, NCT05287321 is actively recruiting participants. Contact the research team at yoominkim@cau.ac.kr for enrollment information.
Where is the NCT05287321 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05287321 clinical trial?
NCT05287321 is sponsored by Yoo-min Kim. The principal investigator is Yoo-min Kim, MD at Chung-Ang University Gwangmyeong Hospital. The trial plans to enroll 58 participants.