STATICH-A
(2026)Objective
Assess the safety and efficacy of long-term antiplatelet treatment after spontaneous intracerebral hemorrhage (ICH) in patients with vascular disease.
Study Summary
• Recurrent symptomatic ICH: 5/34 (15%; 95% CI, 6–31%) with antiplatelets vs 1/35 (3%; 95% CI, 0–18%) avoid — numerically more with antiplatelets.
• Major ischemic events: 3/34 (9%) with antiplatelets vs 7/35 (20%) avoid — numerically fewer with antiplatelets.
• All-cause death: 9/34 (26%) with antiplatelets vs 3/35 (9%) avoid.
• Functional outcome (mRS shift) at 2 years favored avoiding antiplatelets (adjusted common OR, 2.52; 95% CI, 1.03–6.14).
Intervention
Start antiplatelet treatment (physician-chosen agent/dose; aspirin in 59%) vs avoid all antithrombotic treatment.
Inclusion Criteria
Adults ≥18 y with nontraumatic ICH ≥24 h earlier, no underlying structural cause, and an indication for antiplatelet therapy (prior ischemic vascular disease, arterial stents, or known atherosclerotic disease).
Study Design
Arms: Start antiplatelet treatment vs Avoid antiplatelet treatment
Patients per Arm: 34 start antiplatelet vs 35 avoid antiplatelet
Outcome
• Major ischemic events: 9% (3/34) start vs 20% (7/35) avoid.
• Major hemorrhagic events: 18% (6/34) start vs 9% (3/35) avoid.
• Major adverse cardiovascular events: 24% (8/34) start vs 26% (9/35) avoid.
• Death (all-cause): 26% (9/34) start vs 9% (3/35) avoid.
• mRS shift at 2 years: adjusted common OR, 2.52 (95% CI, 1.03–6.14) favoring avoid.
• Serious AEs: 52 (start) vs 36 (avoid); no suspected unexpected serious adverse reactions.
Clinical Question
In adults with spontaneous intracerebral hemorrhage who have an indication for antiplatelet therapy, does starting (vs avoiding) long-term antiplatelet treatment change the risk of recurrent ICH and major ischemic events?
Bottom Line
In this early-terminated, underpowered Scandinavian trial (n=69), starting antiplatelet therapy after ICH produced numerically more recurrent ICHs and deaths and numerically fewer major ischemic events than avoidance; functional outcome at 2 years favored avoiding antiplatelets, but no definitive conclusion could be drawn.
Major Points
- Randomized, open-label, blinded end-point trial (PROBE) in 25 Scandinavian centers; sub-trial of the larger STATICH program (Antiplatelets and Anticoagulants).
- Target sample size was 500; trial terminated early after enrolling only 69 patients over 4+ years due to slow recruitment and lack of funding.
- Primary safety outcome (recurrent symptomatic ICH) occurred in 5/34 (15%) starting antiplatelets vs 1/35 (3%) avoiding antiplatelets — too few events for planned Cox regression.
- Major ischemic events (composite) were less frequent in the antiplatelet group (3 vs 7); all-cause death was higher (9 vs 3).
- Functional status (mRS) at 2 years shifted toward better outcome in the avoid-antiplatelet group (adjusted common OR, 2.52; 95% CI, 1.03–6.14).
- Results will be pooled with RESTART and other ongoing trials (e.g., ASPIRING) in a planned individual-patient-data meta-analysis.
Study Design
- Study Type
- Randomized Controlled Trial (PROBE — Prospective, Randomized, Open-label, Blinded End-point)
- Randomization
- Yes
- Blinding
- Open-label to patients and treating physicians; outcome assessors blinded (blinded end point).
- Sample Size
- 69
- Follow-up
- Minimum 2 years; median complete follow-up 3.3 years (total 222 person-years); last follow-up August 31, 2024
- Centers
- 25
- Countries
- Norway, Sweden, Denmark
Primary Outcome
Definition: Time to first recurrent symptomatic intracerebral hemorrhage (parenchymal or intraventricular bleeding), centrally adjudicated by blinded neuroradiologists.
| Control | Intervention | HR/OR | P-value |
|---|---|---|---|
| - | - | Not estimable (too few events for planned Cox model) (—) | Not reported (no formal statistical inference performed) |
Limitations & Criticisms
- Trial terminated early after enrolling only 69/500 planned patients — severely underpowered; no formal hypothesis testing on primary or most secondary outcomes.
- Long median time from index ICH to randomization (120 days) misses the highest-risk early window (first 3 months post-ICH).
- Selection bias: high proportion of lobar ICH (74% by clinician), low median baseline mRS (1), small median hematoma volume (~5.8 mL), and 38% of screening-log patients considered too unwell to participate.
- Open-label design with unblinded participants and treating physicians introduces potential detection and treatment bias despite blinded outcome adjudication.
- Only 59% of the antiplatelet arm used aspirin; adherence varied 71–100% in start arm and 67–89% in avoid arm; over-the-counter antiplatelet use possible in Denmark and not captured.
- No blood pressure data collected after randomization, limiting confounder adjustment.
- Small number of women (male sex ~62%); results may not generalize to typical ICH populations with more severe strokes.
Citation
Stroke. 2026 (published online June 18, 2026). doi:10.1161/STROKEAHA.125.054990