Pilot study on the evaluation of efficacy, safety, and tolerability of colchicine combined with acetylsalicylic acid versus acetylsalicylic acid alone in the management of minor acute ischemic strokes
Jennifer Nyangui Mapaga, Pupchen Marilyse Gnigone, Bayode Roméo Adegbite, Grass Aurell Mambila Matsalou, Richard Houeze, Annick Andréa Nsounda, Jean-Philippe Neau, Ayola Akim Adegnika, Philomène Kouna NdouongoObjectives:
Stroke constitutes a public health issue globally, with an increased risk of subsequent vascular events. Inflammation is a novel therapeutic target to mitigate this risk. Therefore, this study aimed to evaluate the efficacy, safety, and tolerability of colchicine combined with acetylsalicylic acid in the management of acute minor ischemic strokes (AISs).
Materials and Methods:
This was a randomized controlled open-label study of AIS patients with a high-sensitivity C-reactive protein (hs-CRP) with level of at least 1 mg/L. Two arms were formed; the intervention arm received 0.5 mg colchicine tablets combined with 75 mg acetylsalicylic acid for 14 days, followed by 160 mg/day of acetylsalicylic acid for 3 months. The control arm acetylsalicylic acid alone (300 mg loading dose followed by 160 mg daily for 3 months). Clinical assessments were conducted throughout the follow-up period, and hs-CRP levels were measured at day 14.
Results:
Nineteen participants were enrolled (10 intervention and 9 control). One recurrent ischemic stroke (IS) (11%). A decrease of 1.5 points in the average disability level was observed in the intervention group compared to 1 point in the control group ( p = 0.066). The 14-day hs-CRP mean levels were 1.6 ± 1.9 mg/L in the intervention group versus 4.5 ± 4.3 mg/L in the control group ( p = 0.505). One patient in the control group experienced a hemorrhagic transformation of IS.
Conclusion:
The preliminary results of the COKA-EST (Colchicine in Acute Stroke Trial) study are promising, although the study has some limitations, such as the small sample size insufficient to assess the primary outcome measure of stroke recurrence risk at 3 months.