# Secondary prevention using a statin with or without aspirin among Ghanaian intracerebral hemorrhage survivors: A feasibility randomized trial

## TL;DR

This study tested if aspirin and statins are safe for preventing future strokes in Ghanaian patients who survived a brain bleed.

## Contribution

It is the first feasibility trial assessing aspirin and statin use after intracerebral hemorrhage in a sub-Saharan African population.

## Key findings

- Aspirin with or without atorvastatin was well tolerated in ICH survivors over 12 months.
- No treatment-limiting side effects were observed despite some adverse events.
- Preliminary data suggest no increased risk of recurrent ICH with aspirin/statins.

## Abstract

Intracerebral hemorrhage (ICH) survivors are at high risk for future ischemic vascular events and recurrent ICH. Due to an uncertain risk-benefit ratio, practice guidelines equivocate on whether antiplatelet therapies or statins should be prescribed for secondary prevention in the aftermath of a spontaneous ICH.

To preliminarily assess the tolerability and safety of low dose aspirin with or without atorvastatin at low and high doses for secondary prevention after ICH.

In this single-center feasibility trial in Ghana, participants were randomized to 1 of 6 arms: no aspirin (ASA-0) + no atorvastatin (ATO-0) n = 10); aspirin 75 mg + no atorvastatin (ASA-75 + ATO-0, n = 10); no aspirin + atorvastatin 20 mg (ASA-0 + ATO-20, n = 10); no aspirin + atorvastatin 80 mg (ASA-0 + ATO-80, n = 10); aspirin 75 mg + atorvastatin 20 mg (ASA-75 + ATORVA-20, n = 11); and aspirin 75 mg + atorvastatin 80 mg (ASA-75 + ATORVA 80, n = 11) taken daily for 12 months. All participants received standard of care secondary prevention comprising of antihypertensive medications for blood pressure control. Outcomes assessed included major adverse cardiovascular events (stroke, myocardial infarction, vascular death), treatment-limiting side effects, change in Modified Rankin score and global cognition.

We enrolled 62 eligible recent ICH survivors between January 24, 2021, and March 16, 2022, mean (SD) age of 53 (11.6) years, 30 (48 %) were males. There were 3 deaths, one in each of these arms: ASA-0 + ATO-0; ASA-0 + ATO-20; ASA-0 + ATO-80. There was one non-fatal, ischemic stroke in the ASA-75 + ATO-80 arm and one non-fatal ICH in the ASA-75 + ATO-20 arm. No treatment limiting side effects were recorded.

These feasibility and preliminary data suggest that aspirin with or without atorvastatin up to one year after a spontaneous ICH is well tolerated and may not raise recurrent ICH risk. A definitive large study with longer term follow-up is warranted.