NCT07563673Not yet recruitingPhase 4
Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction（ELASTIC）
Safety and Efficacy of Treatment With Early Low-dose ASpirin Use After Intravenous Thrombolysis for Acute Ischemic Cerebral Infarction (ELASTIC): A Randomized, Open-label, Blinded Endpoint, Clinical Trial
Source: ClinicalTrials.gov · Last updated 8 May 2026
Brief summary (registry, in English)
This study evaluates whether early administration of low-dose aspirin (100mg) at 2 hours post-intravenous thrombolysis, compared to the standard timing of 24 hours, improves functional outcomes in patients with acute ischemic stroke. Intravenous thrombolysis is effective for very early treatment of acute ischemic stroke. However, current guidelines recommend starting antiplatelet therapy 24 hours after thrombolysis to avoid symptomatic intracranial hemorrhage (SICH), a recommendation not based on prospective clinical studies. Early re-occlusion of recanalized arteries due to platelet aggregation occurs in 14-34% of cases and is associated with poor prognosis. The average incidence of SICH is 2.4%, with fatal SICH occurring in only 0.28%. Thus, the impact of re-occlusion on poor prognosis may outweigh the risk of SICH. In this prospective, randomized, open-label trial with blinded endpoint evaluation, participants are assigned to receive aspirin 100mg either at 2 hours (early group) or at 24 hours (standard group) after thrombolysis. The primary outcome is the proportion of patients with a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-2 at 3 months. Safety outcomes include the incidence of SICH and all-cause mortality at 3 months. This study will provide clinical evidence regarding the optimal timing for initiating antiplatelet therapy after thrombolysis in acute ischemic stroke.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 26 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Beijing Chao Yang Hospital
- Diseases
- Stroke
- NCT number
- NCT07563673
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 210
- From 1 May 2026 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe swallowing difficulties, unable to take medication orally
- Oral anticoagulant medication is currently being taken
Other illness
- Accompanied by consciousness disorders, or NIHSS ≥ 20 points
- Accompanied by severe infection or evidence of severe infection
Age
- Age\>65 years old
Other
- Onset time\>3 hours
- CT shows' high-density shadow of middle cerebral artery '
- Accompanied by atrial fibrillation or clearly identified as cardioembolic embolism
- Refusal to sign the informed consent form for this study
- Exclusion criteria for other traditional intravenous thrombolysis
Who the study is looking for
- Age range: 18-65 years old
- Receive rt PA thrombolytic therapy within 3 hours (including 3 hours) of onset
- Signs of brain dysfunction lasting for more than 1 hour
- CT imaging excludes cerebral hemorrhage, and there are no imaging changes corresponding to the patient's physical signs
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijng Chao-Yang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.