NCT05856851CompletedPhase 3
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy (PEARL): A Multicenter, Prospective, Open-label, Blinded Endpoint, Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy in improving the 90-day functional outcome.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 324 (actual)
- First submitted
- 4 May 2023
- Start date
- 1 Aug 2023
- Primary completion date
- 15 Jan 2025
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Stroke
- NCT number
- NCT05856851
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 324
- From 1 Aug 2023 to the primary completion date, 15 Jan 2025
- 2 sites 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
- Contraindication to rt-PA (except time to therapy).
- Planned use of dual antiplatelet therapy within the first 24 hours after mechanical thrombectomy.
- Previous parenchymal organ surgery or biopsy in the last 1 month;
Other illness
- Preoperative intracranial hemorrhage confirmed by cranial CT or MRI.
- Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.
- Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast.
- Any active bleeding or recent bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 1 month;
- Anticipated life expectancy \< 6 months (e.g., malignancy, severe cardiopulmonary disease, etc.).
- Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Lab values
- Coagulation disorder with INR \> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset).
- Platelet count \<50X10\^9/L.
- Known severe renal insufficiency with glomerular filtration rate \<30 ml/min or blood creatinine \>220 μmol/L (2.5 mg/dl).
Other
- Angiographic evaluation showing dissection, severe stenosis, or complete occlusion of the carotid artery, which requires the use of carotid artery stents during the endovascular procedure.
- Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.
- Women who are pregnant or breastfeeding.
- Participation in other clinical trials.
- Suspected vascular occlusion as a result of infective endocarditis.
- Suspected aortic dissection.
- SBP \> 185 mmHg or DBP \> 110 mmHg refractory to treatment.
Who the study is looking for
- Aged 18 years or older.
- Clinical diagnosis of acute ischemic stroke.
- Time from symptom onset to randomization within 24 hours, including wake-up stroke or no-witness stroke; the onset time refers to "Last Known Well" (LKW).
- CTA or MRA confirmed occlusion of the intracranial segment of the internal carotid artery, or M1 or M2 segment of the middle cerebral artery; stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis. Patients with an eTICI score of 2b50-3 on the diagnostic cerebral angiography before mechanical thrombectomy are also eligible for the study.
- Baseline NIHSS of 6-25.
- NCCT/DWI-MRI ASPECTS ≥ 6;
- Pre-stroke mRS score ≤ 1, or mRS \>1 but not related to neurological disease (e.g., amputation, blindness).
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shenzhen Hospital of Southern Medical University Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
Related publications
- Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Patients Without Intravenous Thrombolysis: A Subgroup Analysis of the PEARL Randomized Clinical Trial.J Am Heart Assoc · 2026 · PMID 42924842
- Adjunctive intra-arterial alteplase after near-complete or complete reperfusion in acute ischemic stroke: A post hoc analysis of the PEARL Trial.Int J Stroke · 2026 · PMID 42265863
- Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Acute Stroke: The PEARL Randomized Clinical Trial.JAMA · 2025 · PMID 42262770
This page is information, not medical advice. Discuss any trial with your doctor.