Clinical trial
Étude randomisée contrôlée Par Placebo de Phase II Visant à Mesurer l'Effet Anti-inflammatoire et Anti-sénescence de la quercétine Lors d'Une Chirurgie Cardiaque
Name
2021-2761
Description
The purpose of this study is to test the anti-inflammatory and anti-senescence effects of quercetin during coronary artery by-pass graft surgery.
Trial arms
Trial start
2021-06-04
Estimated PCD
2023-12-01
Trial end
2024-10-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Quercetin
500 mg twice daily
Arms:
Quercetin
Placebo
twice daily
Arms:
Placebo
Size
100
Primary endpoint
Quercetin-associated change in surgery-associated inflammation
Baseline, 1 day and 4 days post-surgery
Quercetin-associated change in surgery-associated marker of senescence
Baseline, 1 day and 4 days post-surgery
Eligibility criteria
Inclusion Criteria:
* to be able to speak French or English;
* to be able to give free and enlighten consent;
* be hospitalized and waiting for a cardiac surgery of revascularization;
* to have had a myocardial infarction (MI) within the past 30 days or to be in a state of stable angina before the surgery.
Exclusion Criteria:
* to be in a stable state without MI in the last 30 days;
* have a cardiac surgery concomitant to the cardiac surgery of revascularization;
* have an infection in the last 30 days;
* to have renal insufficiency (GFR less than 30);
* to have a liver disease (AST, ALT or bilirubin ˃ 2X normal values);
* to have a known cirrhosis;
* to have a past history of breast cancer or other tumors estrogen-dependent;
* to be intolerant to flavonoids, niacine or ascorbic acid;
* take quinolone;
* need for a quinolone during post-op;
* not being able to give a free and enlighten consent;
* not being able to speak French of English;
* take quercetin as a supplement.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, double-blind, placebo-controlled', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Allocation of randomization numbers by the pharmacist provided as a randomization list prepared by the biostatisticians of the Montreal Heart Institute', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-03-13
1 organization
1 product
1 drug
1 indication
Organization
Montreal Heart InstituteProduct
QuercetinIndication
Coronary Artery DiseaseDrug
Varlilumab