Clinical Research Directory

The Stroke Aetiology and VascuLar Disease in Stroke and TIA Study - A Clinical Study Analysing the Effects on Cardiovascular Health and Disease With an Extended Investigation Into Conditions Causative of Stroke and Concomitant Cardiovascular Disease in Patients Admitted for Acute Stroke or TIA

Annually, about 4000 Swedes suffer a recurrent stroke, and for many, their lives change dramatically. To prevent recurring strokes, knowledge about the individual's risk of recurrence is needed to tailor an effective preventive medical treatment. The purpose of the SALSA study is to investigate whether an expanded risk assessment and subsequent treatment can reduce the recurrence of stroke in study patients. Stroke, i.e., infarction/bleeding in the brain, has several different causes that individually or together constitute the risk of recurrence. Furthermore, stroke patients often have concomitant vascular diseases in other vascular beds, which further increases the risk. Every fourth patient with acute stroke or transient ischemic attack (TIA) admitted to any of the stroke wards at Danderyd Hospital, Stockholm, Sweden, is consecutively invited to participate in the SALSA study. Those who accept the study invitation, receive an expanded investigation of the most common causes of cerebral infarction (atherosclerosis, atrial fibrillation, narrowing of the brain\'s small vessels) or brain haemorrhage (presence of the protein amyloid in the vessels, high blood pressure). Due to the high risk of stroke patients having a vascular disease, such as atherosclerosis, the presence of arterial stiffness in the aorta, 24-hour blood pressure, and blood circulation in the legs are examined at the follow-up visit. If vascular disease is detected, expanded preventive treatment is provided. Neither a general investigation of the most common stroke aetiologies in addition to the one assessed to have caused the current stroke nor examinations of other vascular beds are recommended in national stroke guidelines. In addition to the extended risk assessment, the patient will get a written treatment program tailored after the individual patient's risk profile. The compliance to this treatment program will be assessed during a return visit one year after the hospital stay. After this visit, the active participation in the study is completed for the study participant. During the remainder of the follow-up, the study participant will be followed in national medical registers. The remaining 3/4 of patients at Danderyd Hospital constitute the comparison group, who are investigated and treated according to routine and hence do not undergo the additional vascular examinations. Stroke recurrence and other cardiovascular events occurring within the next 5-10 years will be compared between study patients and the comparison group via the national stroke registry containing all stroke and TIA patients at Danderyd Hospital.

Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window

This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhTNK-tPA increases the risk of symptomatic intracranial hemorrhage and mortality. Participants will be randomized to receive either a single bolus of rhTNK-tPA (0.25 mg/kg, max 25 mg) or matching placebo administered intravenously over 5 seconds. Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.

Endovascular Treatment for eXtra-Large Ischemic Stroke

The role of endovascular thrombectomy in patients with extra-large ischemic burden is still unclear. The XL STROKE-2 randomized trial is aiming to investigate the efficacy and safety of mechanical thrombectomy in acute extra-large ischemic stroke patients with large vessel occlusion.

Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

IntraCranial Atherosclerosis Related Large-vessel Occlusion Treated With Urgent Stenting (ICARUS)

The goal of this international, multi-center, randomized clinical trial is to compare two treatment options, early intracranial stenting and continued stent-retriever or aspiration based endovascular treatment, for stroke patients with a large vessel occlusion, who experienced failure of recanalisation after initial treatment due to intracranial atherosclerosis.

Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)

The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke.

CHemical OptImization of Cerebral Embolectomy 2 (CHOICE 2).

Multi-center, randomized, parallel-group, superiority study to compare the efficacy of adjunct intra-arterial rt-PA versus not adjunct intra-arterial rt-PA in the improvement of the efficacy of mechanical thrombectomy in patients with large vessel occlusion acute ischemic stroke.

Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion

The primary hypothesis being tested in this trial is that acute ischemic stroke with isolated internal carotid artery occlusion will have improved clinical outcomes when given early endovascular treatment compared with that of given best medical treatment.

Intra-Arterial Thrombolysis After SUCCESSful Reperfusion in Anterior Circulation Ischemic Stroke

Stroke is a leading cause of disability and mortality worldwide. Despite the clinical benefit of mechanical thrombectomy, 1 out of 2 patients treated are functionally independent at 90 days. Achieving the best possible angiographic reperfusion is a key determinant of clinical outcome in acute ischemic stroke patients with anterior circulation large vessel occlusion. Mechanical thrombectomy is standard treatment for large vessel occlusion stroke patients within 24. In the setting of successful (eTICI ≥2b), adjunct intra-arterial thrombolysis may be a promising therapeutic option allowing recanalization of distal arterial occlusions (not accessible to mechanical devices) and improvement of upstream brain reperfusion by targeting microvascular obstruction. The IA-SUCCESS randomized trial aims to assess the clinical and safety of adjunct intra-arterial thrombolysis vs. no adjunct intra-arterial thrombolysis after successful angiographic reperfusion in patients with acute anterior circulation large vessel occlusion stroke.

Immediate Angioplasty For Acute Ischemic Stroke With Severe Intracranial Atherosclerotic Stenosis

A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial that aims to evaluate the effect of immediate angioplasty (with or without stenting) for acute ischemic stroke (AIS) with severe intracranial atherosclerotic stenosis (ICAS) in improving the 90-day functional outcome.

Trendelenburg Position for Acute Anterior Circulation Ischemic Stroke With Large Artery Atherosclerosis Etiology (HOPES 3)

The effect of head position as a nonpharmacological therapy on acute ischemic stroke (AIS) remains inconclusive. Recent HOPES2 (Head dOwn-Position for acutE moderate ischemic Stroke with large artery atherosclerosis) suggest the safety, feasibility, and potential benefit of the head-down position (HDP) in acute ischemic stroke. The current study aims to investigate the efficacy and safety of HDP in acute moderate ischemic stroke patients with large artery atherosclerosis.

Neuropsychological Rehabilitation Over the Internet

Helsinki University Hospital (HUS) has decided on a strategy to provide digital health care services for several medical specialties - a project called the Health Village (HealthVillage.fi). Within Health Village a specific digital My Path program, iRENE Digital Pathway, has been developed for web-based neuropsychological rehabilitation. iRENE Digital Pathway is a structured program for adults with an acquired brain injury (ABI), which utilizes psychoeducative information and self-evaluation questionnaires for attentional, memory and executive disorders with a feedback, and provides training for internal and external memory and other cognitive strategies. The current study will explore if web-based neuropsychological rehabilitation is a feasible and effective method for carrying out rehabilitation for adults with ABI.

The Efficacy and Safety of Y-3 Intracalvariosseous Injection Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction

A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.

Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy

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.

Tirofiban for Successful Endovascular Stroke Thrombectomy

Up to 50% of acute ischemic stroke patients with large vessel occlusion failed to achieve functional independence even after successful reperfusion therapy, a phenomenon that is referred to as "futile recanalization". The mechanism of futile recanalization is complex, and some studies have shown that it may be related to factors such as tissue no reflow, reocclusion, poor status of collateral circulation, hemorrhagic transformation, impaired cerebrovascular autonomic regulation, and low perfusion volume. Several studies suggested that maximizing the improvement of cerebral reperfusion is still the primary goal of acute large vessel occlusive stroke. Structural and functional alterations in the microvascular system may be a major obstacle to reperfusion. In animal models of cerebral ischemia, downstream microvascular thrombosis may occur in the early stage of cerebral ischemia and before vascular recanalization, which is the main factor leading to incomplete reperfusion and affecting the efficacy of endovascular thrombectomy. Mechanical thrombectomy mainly addressed the occluded large arteries, and does not consider the distal arteries. However, the recanalization of occluded large arteries does not necessarily translate into successful reperfusion of the ischemic tissue supplied by the distal capillaries. Even with complete recanalization, impaired microcirculatory reperfusion may lead to poor clinical outcomes. Therefore, we speculate that at the end of endovascular thrombectomy, microthrombi remain present in the microcirculation of brain tissue in patients with complete or near-complete cerebral angiography, and that microthrombi is more likely to be dissolved than thrombus more proximal to the heart. Therefore, intra-arterial administration of pharmaceutical, such as tirofiban, may be the only possible option to ensure complete reperfusion of ischemic tissue. Tirofiban is a platelet glycoprotein IIb/IIIa receptor antagonist, which has been widely used in acute coronary syndrome, and its role in acute ischemic stroke has attracted more and more attention from stroke experts. Previous studies have suggested that tirofiban can further increase the incidence of successful recanalization, while reducing the reocclusion rate. Whether early administration of intraarterial and intravenous tirofiban can further improve the clinical outcomes of patients with large vessel occlusive stroke after successful mechanical thrombectomy remains unclear.

Establishing Mechanical Thrombectomy at a Limited-volume Stroke Center - Effects on Patient Morbidity and Mortality

The regional health authorities of South-East Norway has commissioned Sørlandet Hospital (SSHF), Norway to establish mechanical thrombectomy in large-vessel occlusion stroke. SSHF is a limited volume stroke center, and introduction of thrombectomy may impose quality challenges. Therefore the implementation will be guided by a simulation based quality assurance program. In this study, we will monitor timelines, technical and clinical outcomes, including adverse events.

Triage of Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions-2

The objective of this study is to create a comprehensive, real-world, multi-center observational registry of consecutive patients admitted to hospitals with acute ischemic stroke (AIS) caused by large vessel occlusions (LVO), who are treated with either endovascular therapy (EVT) or the best available medical management (BMM).

Role of Hypothermia in Endovascular Stroke Thrombectomy

Reducing or suspending the increase of the infarcted core, i.e., "freezing" the ischemic penumbra, may help improve the efficacy of mechanical thrombectomy. Hypothermia effectively reduces the metabolic level of brain tissue, may prolong the time window for recanalization therapy, and its multi-target therapeutic effect make it one of the most promising neuro-protection approach. In recent years, hypothermia has been increasingly used to treat acute ischemic stroke. However, its role in acute ischemic stroke is unclear. The objective of this trial is to investigate whether hypothermia combined with endovascular thrombectomy could add additional benefit without increasing the risk of adverse events such as pneumonia, intracerebral hemorrhage, and mortality.

The Effect of Early Administration of PCSK9 Inhibitor to Acute Ischemic Stroke Patients Associated With Atherosclerosis on the Stroke Prognosis and Lipid Profile

The goal of this clinical trial is to test the effect of proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors) in acute ischemic stroke patients associated with atherosclerosis by investigating 1. the change in lipid profile compared to baseline results 2. the effects on prognosis of stroke The participants will be given PCSK9 inhibitor right after confirmation of acute ischemic stroke, and the investigators will compare the results to the control group, whom are acute ischemic stroke patients treated with conventional lipid lowering therapy, statin and/or ezetimibe.