NCT04907253

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 coronary-artery-disease

Timeline
Completed

Started Jun 2021

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 4, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 15, 2026

Completed
Last Updated

April 15, 2026

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

May 12, 2021

Results QC Date

May 20, 2025

Last Update Submit

April 13, 2026

Conditions

Keywords

InflammationEndotheliumSenescenceVascular reactivity

Outcome Measures

Primary Outcomes (2)

  • Quercetin-associated Change in Surgery-associated Inflammation

    Circulating blood levels of hs-CRP (mg/L) will be measured as well as a panel of circulating inflammatory markers in a subgroup of patients at day 5 post-surgery

    Baseline, 1 day and 4 days post-surgery

  • Quercetin-associated Change in Surgery-associated Marker of Senescence

    Circulating blood levels of ANGPTL2 (ng/L) will be measured in addition to additional circulating markers of inflammation in a sub-group of patients at day 4 post-surgery

    Baseline, 1 day and 4 days post-surgery

Secondary Outcomes (1)

  • Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation

    During surgery

Other Outcomes (1)

  • Patient Follow-up

    Three month post-surgery

Study Arms (2)

Quercetin

ACTIVE COMPARATOR

Patients receiving 500 mg quercetin twice daily

Drug: Quercetin

Placebo

PLACEBO COMPARATOR

Patients receiving placebo twice daily

Drug: Placebo

Interventions

500 mg twice daily

Quercetin

twice daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (3)

  • Noly PE, Labbe P, Thorin-Trescases N, Fortier A, Nguyen A, Thorin E, Carrier M. Reduction of plasma angiopoietin-like 2 after cardiac surgery is related to tissue inflammation and senescence status of patients. J Thorac Cardiovasc Surg. 2019 Sep;158(3):792-802.e5. doi: 10.1016/j.jtcvs.2018.12.047. Epub 2019 Jan 8.

    PMID: 30745045BACKGROUND
  • Mury P, Dagher O, Fortier A, Diaz A, Lamarche Y, Noly PE, Ibrahim M, Page P, Demers P, Bouchard D, Bernier PL, Poirier N, Moss E, Durrleman N, Jeanmart H, Pellerin M, Lettre G, Thorin-Trescases N, Carrier M, Thorin E. Quercetin Reduces Vascular Senescence and Inflammation in Symptomatic Male but Not Female Coronary Artery Disease Patients. Aging Cell. 2025 Aug;24(8):e70108. doi: 10.1111/acel.70108. Epub 2025 May 15.

  • Dagher O, Mury P, Noly PE, Fortier A, Lettre G, Thorin E, Carrier M. Design of a Randomized Placebo-Controlled Trial to Evaluate the Anti-inflammatory and Senolytic Effects of Quercetin in Patients Undergoing Coronary Artery Bypass Graft Surgery. Front Cardiovasc Med. 2021 Oct 20;8:741542. doi: 10.3389/fcvm.2021.741542. eCollection 2021.

MeSH Terms

Conditions

Coronary Artery DiseaseInflammation

Interventions

Quercetin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Dr Eric Thorin
Organization
Montreal Heart Institute

Study Officials

  • Michel Carrier, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Allocation of randomization numbers by the pharmacist provided as a randomization list prepared by the biostatisticians of the Montreal Heart Institute
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2021

First Posted

May 28, 2021

Study Start

June 4, 2021

Primary Completion

December 1, 2023

Study Completion

May 16, 2025

Last Updated

April 15, 2026

Results First Posted

April 15, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations