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Phase 2 STOP-AUST data suggest that the antifibrinolytic agent may be able to reduce ICH in spot sign positive patients with stroke when administered within 2 to 3 hours of onset, warranting further study.
Nawaf Yassi, MBBS, PhD, trial investigator, and consultant neurologist, Royal Melbourne Hospital
New data from the Spot Sign and Tranexamic Acid on Preventing ICH Growth—Australasia Trial (STOP-AUST) suggest that the antifibrinolytic agent, tranexamic acid, may be an effective way to reduce intracerebral hemorrhage (ICH) when administered to patients with stroke within 2 to 3 hours of onset.1
The multicenter, prospective, randomized, double-blind, placebo-controlled, 100-patient phase 2 clinical trial showed a trend toward the reduced growth of ICH in patients who were spot sign positive when given tranexamic acid within the early treatment windows, while there were no significant differences compared to placebo at 4.5 hours of ICH onset.
The data were presented at the 2020 International Stroke Conference (ISC), in Los Angeles, California.
“Further trials using tranexamic acid are ongoing and focusing on ultra-early treatment — within 2 hours. This is where the greatest opportunity for intervention appears to be,” said Nawaf Yassi, MBBS, PhD, trial investigator, and consultant neurologist, Royal Melbourne Hospital, in a statement. “Tranexamic acid is inexpensive, safe and widely available. Our results and others provide great impetus for further, focused research using this treatment.”
Baseline ICH volume was 13.8mL (range, 7.8—32.0) for the intervention group (n = 50) and 15.6mL (range, 7.9–33.4) for the placebo group (n = 50). There was ICH growth, defined as either 33% or 6 mL increase from baseline, in 44% (n = 22) of the tranexamic acid group, which was ultimately similar to the 52% (n = 26) of the placebo group, for an adjusted odds ratio (aOR) of 0.72 (95% CI, 0.32–1.59; P = .41).
All told, when treated within ≤3 hours of onset (n = 66), the aOR of hematoma growth was 0.41 (95% CI, 0.15—1.12; P = .06), and when treated within ≤2 hours of onset, the aOR was 0.19 (95% CI, P = .07). In comparison, those treated within in the 3- to 4-hour window had an aOR of 2.45 (95% CI, 0.52—11.57; P = .06).
“There is no statistically significant difference in ICH growth in patients with ‘spot sign’ who received tranexamic acid vs. placebo within 4.5 hours of stroke onset, but there is a trend towards reduced hematoma growth in patients receiving tranexamic acid vs. placebo in the ultra-early window ≤3hr and ≤2hr, which warrants further study and research,” Yassi and colleagues detailed.2
Additionally, absolute ICH growth volume by the 24-hour mark, adjusted for baseline ICH volume was 1.9mL (interquartile range [IQR], 0.2—9.5) for the tranexamic acid group, compared to 3.4mL (IQR, 0–16) for placebo (difference adjusted, -1.8 (95% CI, -5.2 to 1.5; P = .41). Likewise, absolute intraventricular hematoma (IVH) growth volume was 0 mL for both groups (difference adjusted, 0; 95% CI, -0.04 to 0.04; P >.99).
Modified Rankin Scale (mRS) scores of 0-4 or a return to baseline at 3 months occurred in 68% (n = 34) of the tranexamic acid group compared to 80% (n = 40) of the placebo group (aOR, 0.33; 95% CI, 0.09—1.23; P = .099). On the other hand, an mRS score of 0-3 or return to baseline at 3 months occurred in 56% (n = 28) and 46% (n = 23) of the tranexamic acid and placebo groups, respectively (aOR, 1.64; 95% CI, 0.63—4.24; P = .31).
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1. Study finds trend toward benefit in using blood-clotting agent for bleeding stroke [press release]. Los Angeles, CA: American Stroke Association; Published February 21, 2020. newsroom.heart.org/news/study-finds-trend-toward-benefit-in-using-blood-clotting-agent-for-bleeding-stroke. Accessed February 25, 2020.
2. Saini V. The Spot Sign and Tranexamic Acid On Preventing ICH Growth - AUStralasia Trial: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial. ISC website. Published February 21, 2020. professional.heart.org/professional/ScienceNews/UCM_505647_STOP-AUST-Clinical-Trial-Details.jsp. Accessed February 25, 2020.