Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
Study NCT ID:
NCT06689566
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2024-11-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Evaluating Metabolic and Anti-inflammatory Effect of Genistein on Post-myocardial Infarction Patients
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if genistein works to provide a beneficial effect to show lipid lowering effect and anti-inflammatory effects and slow the progression of atherosclerosis in post-myocardial infarction adults. It will also learn about the safety of genistein. The main questions it aims to answer are:
Does genistein lower triglyceride in participants? What medical problems do participants have when taking genistein? Researchers will compare the baseline, under treatment and washout period triglyceride, hsCRP to see if genistein works to decrease inflammation.
Participants will:
Take genistein every day for 3 months with a fixed dose manner. Afterwards, there will be 3 months washout period.
Visit the clinic once every month for checkups and tests. Keep a diary of their symptoms.
Does genistein lower triglyceride in participants? What medical problems do participants have when taking genistein? Researchers will compare the baseline, under treatment and washout period triglyceride, hsCRP to see if genistein works to decrease inflammation.
Participants will:
Take genistein every day for 3 months with a fixed dose manner. Afterwards, there will be 3 months washout period.
Visit the clinic once every month for checkups and tests. Keep a diary of their symptoms.
Detailed Description:
Background Current medical treatment for slowing the progression of atherosclerosis focus on lipid control and anti-platelet agent use. Systemic inflammation is associated with an increased risk of cardiovascular events, independent of the cholesterol level. Recent studies showed that anti-inflammatory therapy with canakinumab or colchicine led to a significantly lower rate of recurrent cardiovascular events than placebo, independent of lipid-level lowering. Genistein was reported to be associated with anti-inflammatory and lipid lowering effects in preclinical studies. Thus, we hypothesized that genistein could provide a beneficial effect to show lipid lowering effect and anti-inflammatory effects and slow the progression of atherosclerosis.
Method The study is a phase 2 sing-center, dose-escalation clinical trial to evaluate the benefit of genistein compared to placebo among stable post-MI patients receiving standard of care therapy who have been selected for an elevated inflammatory burden as determined by high sensitivity C-reactive protein (hsCRP) \> 0.1 mg/dL
Screening will take place no earlier than 28 days after the index MI and on stable (at least 4 weeks) long term medication. Evaluations will include hsCRP and determination of cancer, tuberculosis status among other measurements and procedures and will be done at a cardiology clinic. For patients who underwent percutaneous coronary intervention (PCI) at different hospital admission than the qualifying MI; screening can be initiated no earlier than 28 days following this procedure.
Intervention Patients will be screened for suitability of genistein treatment, and the trial would be initiated after informed consent. After initiation, the patients will receive genistein 250mg BID orally for complete 3 months. Afterwards, there will be 3 months washout period. Patients would then be followed for outcome measurement.
Follow-up Laboratory data would be checked 0, 1, 3, 6 months as well as clinics follow-up. Echocardiography and 6-minute walking test will be checked at 0, 3 months. Major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, hospitalization for heart failure, or confirmed death from cardiovascular causes will be documented. Further follow-up would be arranged according to local guidelines until 2027/12/31 then according to patient's condition and local medical guidance.
Method The study is a phase 2 sing-center, dose-escalation clinical trial to evaluate the benefit of genistein compared to placebo among stable post-MI patients receiving standard of care therapy who have been selected for an elevated inflammatory burden as determined by high sensitivity C-reactive protein (hsCRP) \> 0.1 mg/dL
Screening will take place no earlier than 28 days after the index MI and on stable (at least 4 weeks) long term medication. Evaluations will include hsCRP and determination of cancer, tuberculosis status among other measurements and procedures and will be done at a cardiology clinic. For patients who underwent percutaneous coronary intervention (PCI) at different hospital admission than the qualifying MI; screening can be initiated no earlier than 28 days following this procedure.
Intervention Patients will be screened for suitability of genistein treatment, and the trial would be initiated after informed consent. After initiation, the patients will receive genistein 250mg BID orally for complete 3 months. Afterwards, there will be 3 months washout period. Patients would then be followed for outcome measurement.
Follow-up Laboratory data would be checked 0, 1, 3, 6 months as well as clinics follow-up. Echocardiography and 6-minute walking test will be checked at 0, 3 months. Major cardiovascular event, defined as nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, an arterial revascularization procedure, hospitalization for heart failure, or confirmed death from cardiovascular causes will be documented. Further follow-up would be arranged according to local guidelines until 2027/12/31 then according to patient's condition and local medical guidance.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: