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

Product
Quercetin