Trial Outcomes & Findings for Quercetin in Coronary Artery By-pass Surgery (NCT NCT04907253)
NCT ID: NCT04907253
Last Updated: 2026-04-15
Results Overview
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
COMPLETED
PHASE2
100 participants
Baseline, 1 day and 4 days post-surgery
2026-04-15
Participant Flow
coronary unit patients waiting for CABG surgery
Participant milestones
| Measure |
Placebo
receive placebo BID
|
Quercetin
reveive quercetin 500mg twice a day
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
47
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Placebo
receive placebo BID
|
Quercetin
reveive quercetin 500mg twice a day
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Quercetin in Coronary Artery By-pass Surgery
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
Placebo BID
|
Quercetin
n=47 Participants
Quercetin 500mg BID
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=193 Participants
|
17 Participants
n=193 Participants
|
42 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=193 Participants
|
30 Participants
n=193 Participants
|
55 Participants
n=386 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 2 • n=193 Participants
|
68 years
STANDARD_DEVIATION 1 • n=193 Participants
|
67 years
STANDARD_DEVIATION 1 • n=386 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=193 Participants
|
8 Participants
n=193 Participants
|
19 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=193 Participants
|
39 Participants
n=193 Participants
|
78 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=193 Participants
|
47 Participants
n=193 Participants
|
97 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=193 Participants
|
47 participants
n=193 Participants
|
97 participants
n=386 Participants
|
|
Inflammatory status (hs-CRP values)
|
7.6 mg/L
STANDARD_DEVIATION 2.5 • n=193 Participants
|
7.1 mg/L
STANDARD_DEVIATION 1.8 • n=193 Participants
|
7.3 mg/L
STANDARD_DEVIATION 1.5 • n=386 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 day and 4 days post-surgeryPopulation: Men and women treated with quercetin or placebo starting 2 days before surgery
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
Outcome measures
| Measure |
Placebo
n=50 Participants
Placebo BID
|
Quercetin
n=47 Participants
Quercetin 500mg BID
|
|---|---|---|
|
Quercetin-associated Change in Surgery-associated Inflammation
Baseline men
|
7 mg/L
Standard Deviation 2
|
8 mg/L
Standard Deviation 3
|
|
Quercetin-associated Change in Surgery-associated Inflammation
t1 men
|
113 mg/L
Standard Deviation 6
|
119 mg/L
Standard Deviation 6
|
|
Quercetin-associated Change in Surgery-associated Inflammation
Baseline Women
|
9 mg/L
Standard Deviation 5
|
3 mg/L
Standard Deviation 1
|
|
Quercetin-associated Change in Surgery-associated Inflammation
t1 women
|
87 mg/L
Standard Deviation 10
|
109 mg/L
Standard Deviation 16
|
|
Quercetin-associated Change in Surgery-associated Inflammation
t4 women
|
85 mg/L
Standard Deviation 10
|
19 mg/L
Standard Deviation 17
|
|
Quercetin-associated Change in Surgery-associated Inflammation
t4 men
|
127 mg/L
Standard Deviation 8
|
128 mg/L
Standard Deviation 7
|
PRIMARY outcome
Timeframe: Baseline, 1 day and 4 days post-surgeryPopulation: Men and women treated with quercetin or placebo starting 2 days before surgery
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
Outcome measures
| Measure |
Placebo
n=47 Participants
Placebo BID
|
Quercetin
n=50 Participants
Quercetin 500mg BID
|
|---|---|---|
|
Quercetin-associated Change in Surgery-associated Marker of Senescence
Baseline women
|
6.8 ng/L
Standard Error 0.5
|
5.5 ng/L
Standard Error 0.4
|
|
Quercetin-associated Change in Surgery-associated Marker of Senescence
t1 women
|
6.7 ng/L
Standard Error 0.4
|
7.4 ng/L
Standard Error 1.0
|
|
Quercetin-associated Change in Surgery-associated Marker of Senescence
t4 women
|
7.5 ng/L
Standard Error 0.6
|
7.3 ng/L
Standard Error 0.4
|
|
Quercetin-associated Change in Surgery-associated Marker of Senescence
baseline men
|
5.8 ng/L
Standard Error 0.3
|
6.2 ng/L
Standard Error 0.2
|
|
Quercetin-associated Change in Surgery-associated Marker of Senescence
t1 men
|
7.0 ng/L
Standard Error 0.3
|
7.0 ng/L
Standard Error 0.2
|
|
Quercetin-associated Change in Surgery-associated Marker of Senescence
t4 men
|
7.2 ng/L
Standard Error 0.3
|
7.5 ng/L
Standard Error 0.3
|
SECONDARY outcome
Timeframe: During surgeryPopulation: Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation
A discarded segment of the mammary artery will be collected at the end of the cardiac surgery when available. One portion of the segment will be used to study the endothelium-dependent relaxation ex vivo. Segments will be mounted on a wire myograph. After an equilibration period, it will be pre-contracted with U46619 (0.1 µM): when the pre-contraction is stable, a cumulative dose-response curve to acetylcholine is built to induce an endothelium-dependent relaxation. Relaxation will be determined by the vascular sensitivity to acetylcholine (nM). IMPORTANT: at completion of the study, the analysis revealed that during the surgery, only 34 arterial segments from patients in the quercetin group and 44 segments from patients in the placebo group were made available by the surgeon. Therefore, only these 78 arterial segments were analyzed for this outcome measure of the ITT population (n=97).
Outcome measures
| Measure |
Placebo
n=34 artery
Placebo BID
|
Quercetin
n=44 artery
Quercetin 500mg BID
|
|---|---|---|
|
Acetylcholine Concentration (nM) Required for EC50 in Endothelium-dependent Relaxation
|
101 nM
Interval 7.0 to 228.0
|
151 nM
Interval 48.0 to 409.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Three month post-surgeryPopulation: No event (death, recurrent angina, graft failure) occured after surgery during the following 3 months
Any event that occured during the three months following surgery
Outcome measures
Outcome data not reported
Adverse Events
Placebo
Quercetin
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place