STATICH-A
Study of Antithrombotic Treatment After Intracerebral Hemorrhage-Antiplatelets: A Randomized Trial
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.
Design
Study Type: Randomized Controlled Trial (PROBE — Prospective, Randomized, Open-label, Blinded End-point)
Randomization: 1
Blinding: Open-label to patients and treating physicians; outcome assessors blinded (blinded end point).
Enrollment Period: August 31, 2018 – December 23, 2022
Follow-up Duration: 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
Sample Size: 69
Analysis: Intention-to-treat; time-to-first-event Cox regression planned but not feasible due to few events — results reported as absolute numbers with Kaplan-Meier plots. Ordinal logistic regression for mRS shift, adjusted for age (<70/≥70) and lobar/nonlobar location.
Inclusion Criteria
- Adults ≥18 years of age
- Spontaneous, nontraumatic intracerebral hemorrhage with no underlying structural cause
- At least 24 hours after ICH symptom onset (protocol amended to remove the 180-day upper limit)
- Indication for antiplatelet therapy: secondary prevention after prior ischemic vascular disease, arterial stents, or primary prevention with known atherosclerotic arterial disease
- Mandatory brain CT or MRI scan confirming the ICH before inclusion
- Written consent from the patient (Sweden, Denmark) or proxy consent from a relative/representative if the patient lacked capacity (Norway only)
Exclusion Criteria
- Compelling indication for antiplatelet therapy (e.g., recent coronary artery stenting)
- Contraindication to the antiplatelet drug (e.g., low platelet count)
- Pregnancy or breastfeeding
- Women of childbearing potential not using contraception
- Malignancy with life expectancy <2 years
Arms
| Field | Start antiplatelet treatment | Control |
|---|---|---|
| Intervention | Start antiplatelet therapy (agent and dose chosen by including physician; aspirin in ~59%; dual-antiplatelet allowed but not used). | Avoid all antithrombotic treatment; standard care otherwise. |
| Duration | Long-term (≥2 years; median follow-up 3.3 years) | Long-term (≥2 years; median follow-up 3.3 years) |
Outcomes
| Outcome | Type | Control | Intervention | HR / OR / RR | P-value |
|---|---|---|---|---|---|
| Time to first recurrent symptomatic intracerebral hemorrhage (parenchymal or intraventricular bleeding), centrally adjudicated by blinded neuroradiologists. | Primary | Not estimable (too few events for planned Cox model) | Not reported (no formal statistical inference performed) | ||
| Major ischemic events (composite: ischemic stroke, MI, mesenteric ischemia, PAD occlusion, DVT, PE, revascularization) | Secondary | Not estimable | Not reported | ||
| Ischemic stroke (individual) | Secondary | — | — | ||
| Myocardial infarction | Secondary | — | — | ||
| Major hemorrhagic events (composite: symptomatic ICH + other intracranial + major extracranial hemorrhage) | Secondary | Not estimable | Not reported | ||
| Major adverse cardiovascular events (MACE composite) | Secondary | Not estimable | Not reported | ||
| Death from any cause | Secondary | Not estimable | Not reported | ||
| Functional status at 2 years (modified Rankin Scale shift) | Secondary | 2.52 | Significant (95% CI excludes 1) | ||
| Total serious adverse events | Adverse | 88 (52 start vs 36 avoid) | |||
| Suspected unexpected serious adverse reactions | Adverse | 0 | |||
| All major hemorrhagic events | Adverse | Intracranial | |||
| Note | Adverse | All 6 patients with recurrent ICH had a prior symptomatic ischemic event; 5 of 6 had prior ischemic stroke or TIA. Locations of recurrent ICH: 3 lobar, 1 deep, 1 infratentorial, 1 multi-site. | |||
Subgroup Analysis
Randomization used minimization on age (<70 vs ≥70), lobar vs nonlobar ICH location, probability of good 6-month outcome (<0.15 vs ≥0.15), days from index ICH (0–6, 7–30, >30), and choice of aspirin vs other antiplatelet. No formal subgroup analyses reported due to small event counts.
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.
Funding
Investigator-initiated; supported by South-Eastern Norway Regional Health Authority and other Scandinavian public funding sources (per publication); no pharmaceutical company involvement.
Based on: STATICH-A (Stroke, 2026)
Authors: Eilertsen H, Larsen KT, Forfang E, ..., et al.; on behalf of the STATICH Investigators
Citation: Stroke. 2026 (published online June 18, 2026). doi:10.1161/STROKEAHA.125.054990
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