STATICH
(2026)Objective
To assess the safety and efficacy of long-term antiplatelet treatment in patients who survived spontaneous intracerebral hemorrhage (ICH) and had an indication for antiplatelet therapy.
Study Summary
• Recurrent ICH: 15% (5/34, 95% CI 6-31%) with antiplatelets vs 3% (1/35, 95% CI 0-18%) avoiding antiplatelets
• Major ischemic events: 9% (3/34, 95% CI 3-24%) with antiplatelets vs 20% (7/35, 95% CI 10-37%) avoiding antiplatelets
• Numerically more recurrent ICHs but fewer ischemic events with antiplatelet treatment
• 88 serious adverse events, no suspected unexpected serious adverse reactions
Intervention
Start antiplatelet treatment (drug and dose at physician discretion, dual-antiplatelet allowed) vs avoid all antithrombotic treatment after spontaneous ICH.
Inclusion Criteria
Adults ≥18 years with nontraumatic ICH (no underlying structural cause) at least 24 hours before inclusion, with an indication for antiplatelet treatment (secondary prevention for prior ischemic vascular disease, arterial stents, or primary prevention with known atherosclerotic disease); mandatory brain CT/MRI confirming ICH; written consent.
Study Design
Arms: Start antiplatelet treatment (n=34) vs Avoid antiplatelet treatment (n=35)
Patients per Arm: 34 vs 35
Outcome
• Major ischemic events: 9% (95% CI 3-24%) with antiplatelets vs 20% (95% CI 10-37%) avoiding antiplatelets
• Numerically more bleeding and fewer ischemic events in the antiplatelet group
• Trial underpowered; will contribute to planned individual patient-data meta-analysis
Bottom Line
In ICH survivors with an indication for antiplatelet therapy, starting antiplatelets was associated with numerically more recurrent ICHs but fewer major ischemic events compared with avoidance; the trial was stopped early for slow recruitment and is underpowered, so the dilemma remains unresolved pending the planned individual patient-data meta-analysis.
Major Points
- Scandinavian randomized open-label, blinded end-point trial of starting vs avoiding antiplatelets after spontaneous ICH
- Stopped early due to slow recruitment: only 69 of 500 planned patients enrolled (Aug 2018 - Dec 2022)
- Recurrent symptomatic ICH numerically more frequent in start-antiplatelet group (15% vs 3%)
- Major ischemic events numerically less frequent in start-antiplatelet group (9% vs 20%)
- Findings broadly consistent with RESTART signal favoring antiplatelet restart for ischemic protection
- Data will contribute to a planned collaborative individual patient-data meta-analysis
Study Design
- Study Type
- Randomized, multicenter, open-label, blinded end point, parallel-group trial
- Randomization
- Yes
- Blinding
- Open-label treatment; outcome assessors and neuroradiologists blinded to allocation (PROBE design)
- Sample Size
- 500
- Follow-up
- Minimum 2 years
- Centers
- 25
- Countries
- Norway, Sweden, Denmark
Primary Outcome
Definition: Recurrent symptomatic intracerebral hemorrhage (bleeding within brain parenchyma or into ventricular system; excludes extradural, subdural, subarachnoid)
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| 1/35 (3%; 95% CI 0%-18%) in avoid antiplatelet group | 5/34 (15%; 95% CI 6%-31%) in start antiplatelet group | - (Start 6%-31%; Avoid 0%-18%) |
Limitations & Criticisms
- Severely underpowered: only 69 of 500 planned patients enrolled before early stoppage
- Open-label treatment (PROBE design) — patients not blinded
- Choice of antiplatelet agent and dosage left to including physician (heterogeneous intervention)
- Wide, overlapping confidence intervals preclude definitive conclusions
- Over-the-counter antiplatelet use in Denmark not specified in protocol
- Slow recruitment may reflect clinician equipoise gap or patient frailty, raising concerns about generalizability
Citation
Stroke. 2026;57:00-00. DOI: 10.1161/STROKEAHA.125.054990