Summary of results obtained in the phase 2 IQ clinical trial
| Laboratory biomarkers . | IQ (n = 22) . | Placebo (n = 22) . | ||
|---|---|---|---|---|
| Baseline . | After treatment . | Baseline . | After treatment . | |
| Plasma sP-selectin levels (ng/mL)∗ | 30.3 ± 9.9 | 30.4 ± 10.6 | 32.1 ± 8.4 | 32.8 ± 9.2 |
| TEG∗ | ||||
| Clot formation time (min) | 4.6 ± 1.4 | 4.8 ± 1.3 | 4.3 ± 1.3 | 4.0 ± 1.0 |
| Reaction time (min) | 1.2 ± 0.3 | 1.2 ± 0.3 | 1.3 ± 0.7 | 1.0 ± 0.2 |
| α-angle (degree) | 73.4 ± 3.4 | 72.5 ± 4.0 | 73.1 ± 5.5 | 75.2 ± 3.3 |
| Maximal amplitude (mm) | 71.3 ± 5.1 | 70.4 ± 6.7 | 71.1 ± 5.8 | 72.1 ± 5.6 |
| CI (AU)† | 3.0 ± 1.5 | 2.7 ± 1.7 | 3.3 ± 1.5 | 3.7 ± 1.3 |
| Whole-blood platelet aggregation (impedance, ohms)∗ | ||||
| Thrombin (0.1 U) | 31 ± 14.5 | 31.7 ± 13.3 | 35.8 ± 10.3 | 33.6 ± 12.9 |
| ADP (10 μM) | 13.1 ± 6.4 | 12.9 ± 6.2 | 17.7 ± 7.4 | 14.1 ± 7.2 |
| Arachidonic acid (5 mM) | 14.1 ± 7.7 | 12.7 ± 8.1 | 12.2 ± 6.9 | 12.9 ± 7.1 |
| Collagen (1 μg/mL)† | 12.4 ± 6.9 | 8.5 ± 5.6 | 13.6 ± 5.2 | 12.6 ± 6.2 |
| Collagen (5 μg/mL) | 14.2 ± 6.1 | 14.8 ± 4.9 | 18 ± 6.2 | 17.2 ± 5.9 |
| TF‡ | ||||
| TF+ MVs (number per mL) | 1551 (404, 6379) | 1723 (516, 7181) | 2468 (603, 6827) | 1515 (440, 3830) |
| TF+ MVs PCA (fmol) | 257 (148, 927) | 362 (166, 834) | 414 (122, 859) | 498 (307, 923) |
| PBMC TF mRNA expression (fold change)§,† | 1.41 (0.46, 6.11) | 0.43 (0.29, 2.19) | NA | NA |
| PDI‡ | ||||
| Plasma PDI reductase activity (pmol/min per μL)† | 16 (14, 27) | 16 (13, 21) | 19 (16, 23) | 20 (17, 25) |
| Plasma PDI antigen (ng/mL) | 2.14 (1.61, 2.96) | 2.18 (1.77, 3.31) | 2.08 (1.88, 2.31) | 2.23 (1.75, 2.72) |
| Other markers of coagulation∗ | ||||
| D-dimer (μg/mL) | 1.5 ± 0.8 | 1.7 ± 1.1 | 1.6 ± 1.1 | 1.9 ± 1.8 |
| Thrombin–antithrombin complexes (ng/mL) | 2.7 ± 1.4 | 2.7 ± 1.7 | 2.5 ± 0.9 | 2.4 ± 1.1 |
| Plasma quercetin levels (ng/mL)∗ | NA | 253 ± 330 | NA | 15 ± 17 |
| Laboratory biomarkers . | IQ (n = 22) . | Placebo (n = 22) . | ||
|---|---|---|---|---|
| Baseline . | After treatment . | Baseline . | After treatment . | |
| Plasma sP-selectin levels (ng/mL)∗ | 30.3 ± 9.9 | 30.4 ± 10.6 | 32.1 ± 8.4 | 32.8 ± 9.2 |
| TEG∗ | ||||
| Clot formation time (min) | 4.6 ± 1.4 | 4.8 ± 1.3 | 4.3 ± 1.3 | 4.0 ± 1.0 |
| Reaction time (min) | 1.2 ± 0.3 | 1.2 ± 0.3 | 1.3 ± 0.7 | 1.0 ± 0.2 |
| α-angle (degree) | 73.4 ± 3.4 | 72.5 ± 4.0 | 73.1 ± 5.5 | 75.2 ± 3.3 |
| Maximal amplitude (mm) | 71.3 ± 5.1 | 70.4 ± 6.7 | 71.1 ± 5.8 | 72.1 ± 5.6 |
| CI (AU)† | 3.0 ± 1.5 | 2.7 ± 1.7 | 3.3 ± 1.5 | 3.7 ± 1.3 |
| Whole-blood platelet aggregation (impedance, ohms)∗ | ||||
| Thrombin (0.1 U) | 31 ± 14.5 | 31.7 ± 13.3 | 35.8 ± 10.3 | 33.6 ± 12.9 |
| ADP (10 μM) | 13.1 ± 6.4 | 12.9 ± 6.2 | 17.7 ± 7.4 | 14.1 ± 7.2 |
| Arachidonic acid (5 mM) | 14.1 ± 7.7 | 12.7 ± 8.1 | 12.2 ± 6.9 | 12.9 ± 7.1 |
| Collagen (1 μg/mL)† | 12.4 ± 6.9 | 8.5 ± 5.6 | 13.6 ± 5.2 | 12.6 ± 6.2 |
| Collagen (5 μg/mL) | 14.2 ± 6.1 | 14.8 ± 4.9 | 18 ± 6.2 | 17.2 ± 5.9 |
| TF‡ | ||||
| TF+ MVs (number per mL) | 1551 (404, 6379) | 1723 (516, 7181) | 2468 (603, 6827) | 1515 (440, 3830) |
| TF+ MVs PCA (fmol) | 257 (148, 927) | 362 (166, 834) | 414 (122, 859) | 498 (307, 923) |
| PBMC TF mRNA expression (fold change)§,† | 1.41 (0.46, 6.11) | 0.43 (0.29, 2.19) | NA | NA |
| PDI‡ | ||||
| Plasma PDI reductase activity (pmol/min per μL)† | 16 (14, 27) | 16 (13, 21) | 19 (16, 23) | 20 (17, 25) |
| Plasma PDI antigen (ng/mL) | 2.14 (1.61, 2.96) | 2.18 (1.77, 3.31) | 2.08 (1.88, 2.31) | 2.23 (1.75, 2.72) |
| Other markers of coagulation∗ | ||||
| D-dimer (μg/mL) | 1.5 ± 0.8 | 1.7 ± 1.1 | 1.6 ± 1.1 | 1.9 ± 1.8 |
| Thrombin–antithrombin complexes (ng/mL) | 2.7 ± 1.4 | 2.7 ± 1.7 | 2.5 ± 0.9 | 2.4 ± 1.1 |
| Plasma quercetin levels (ng/mL)∗ | NA | 253 ± 330 | NA | 15 ± 17 |
Differences in posttreatment measures were assessed with ANCOVA and, for non-Gaussian–distributed data, either with the Wilcoxon rank-sum test or the Spearman test. Posttreatment value comparisons were intentionally not performed based on our a priori statistical analytical plan.
ADP, adenosine 5′-diphosphate; AU, arbitrary units; NA, not applicable.
Mean ± SD.
Statistically significant differences observed among the IQ and placebo groups.
Median (interquartile range [IQR]).
n = 20.