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Stroke clinical trials

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NCT ID: NCT06146790 Recruiting - Clinical trials for Acute Ischemic Stroke

Evaluation of Endovascular Treatment in Acute Intracranial Distal Medium Vessel Occlusion Stroke

Start date: December 14, 2023
Phase: N/A
Study type: Interventional

Rationale: Distal Medium Vessel Occlusion (MeVO) are thought to cause as many as 25% to 40% of all acute ischemic strokes (AIS). Despite their relatively high frequency, there is no consensus regarding the optimal management of these patients. However, the fact that AIS related to MeVO often results in significant disability despite best medical treatment (including intravenous thrombolysis, IVT) calls for novel treatment approaches. Fortunately, a growing number of non-randomized studies have now been published demonstrating the feasibility of endovascular treatment (EVT) for MeVO strokes. These studies have demonstrated that distal EVT leads to high rates of successful reperfusion and may be performed with a comparable safety profile to that of EVT for proximal arterial occlusions. Therefore, a strong rational exists to test the safety and efficacy of EVT for MeVO stokes in a prospective randomized clinical trial. Objectives: The primary objective of this study is to evaluate the hypothesis that endovascular thrombectomy is superior to standard medical management in achieving more favorable outcomes according to the modified Rankin Scale scores at 90 days in subjects presenting with acute ischemic stroke related to a distal medium vessel occlusion within 24 hours from symptom onset (defined as time last know well, TLKW). Secondary objectives include the assessment of the cost-effectiveness of endovascular thrombectomy in the medium vessel occlusion (MeVO) population as well as its impact on health-related quality of life. Study design: The study is a prospective, multicenter, investigational, randomized, controlled, open-label study with blinded endpoint evaluation (PROBE design) and an adaptive design with population enrichment. Study population: Subjects presenting with acute ischemic stroke within 24 hours from TLKW and whose strokes are attributable to a distal medium vascular occlusion defined as co/non-dominant M2 segment or M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3 segments) with evidence of salvageable brain tissue on perfusion imaging, M2 segment vessel diameter should not exceed 2.0 mm. Primary outcome: Shift in distribution of all levels of the 90-day the modified Rankin Scale with levels 5-6 combined (mRS; 0, 1, 2, 3, 4, 5-6) as assessed by structured assessment.

NCT ID: NCT06144866 Recruiting - Ischemic Stroke Clinical Trials

Evaluataion of NOAC Levels in Acute Stroke

Start date: May 1, 2020
Phase:
Study type: Observational [Patient Registry]

Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended over warfarin in preventing stroke and thromboembolism among patients with atrial fibrillation (AF) in several guidelines. To evaluate the pharmacological effects of NOACs, directly measuring the concentration is the most arbitrary way since the correlation between concentration and common coagulation tests are not reliable. Our previous investigation reported under the fixed dose regimen, dabigatran exposure increased in elderly, renal impairments and patients with multiple co-morbid conditions. Our data also showed difference in NOACs exposure in Asians. For example, patients under rivaroxaban, in comparison to apxiaban, were more likely to have lower than expected range drug level. Furthermore, the NOACs concentration also affected by the prescription pattern of physicians (non-compliant to labeled dose) and patients' behavior (poor medication adherence). The relationship between NOACs exposure and safety has been elucidated in large-scale clinical trials. As the NOACs level increased, the risk for bleeding increased, too. Nevertheless, no additional protection was noted with increased NOACs levels. In post marketing surveillance, bleeding and thrombotic events have been reported. Investigating the NOACs level among these patients helps evaluating the residual drug in the body, which could be a reference for clinical decision in emergent situation. Specific purpose: Investigate the correlation between NOACs concentration upon the arrival of emergency department (ED) and important clinical outcomes including systemic thromboembolism, and major bleeding. Direction for investigation: 1. Prospectively record the NOACs concentration among AF patients under NOACs therapy and suffered from ischemic stroke (IS), transient ischemic attack (TIA), intracerebral hemorrhage (ICH) and other major bleeding. 2. Investigate the correlation between NOACs concentration upon ED arrival and thromboembolic or bleeding events. 3. Propose a therapeutic range for NOACs, in order to provide a guide for important decision in acute setting.

NCT ID: NCT06143488 Recruiting - Clinical trials for Acute Ischemic Stroke

Endovascular Therapy Versus Best Medical Treatment for Acute Large Vessel Occlusion Stroke With Low NIHSS

Start date: January 4, 2024
Phase: N/A
Study type: Interventional

Patients presenting with mild symptoms of acute ischemic stroke are common and account for approximately half of all acute ischemic stroke. About 30% of patients with minor stroke have a 90-day functional disability. Radiologically proven a large vessel occlusion (LVO) in patients with minor stroke is a well-established predictor of poor outcomes, while the poor outcomes following best medical management in patients with minor stroke with the underlying presence of a LVO are mainly driven by the occurrence of early neurological deterioration (END). Considering the well-known strong association between lack of arterial recanalization and END, endovascular therapy (EVT) appears as an attractive option to improve functional outcomes for LVO-related patients with stroke with mild symptoms. Whether EVT is safe and effective in patients with mild stroke with an LVO is currently debated, since these patients were typically excluded from the pivotal EVT trials. The current study aimed to further test the hypothesis that endovascular therapy would be superior to medical management with respect to functional recovery among low NIHSS patients caused by acute large-vessel occlusion in the anterior circulation.

NCT ID: NCT06139692 Recruiting - Clinical trials for Acute Ischemic Stroke

Comparison of Perioperative Conscious Sedation During Endovascular Thrombectomy in Acute Ischemic Stroke

PEACE
Start date: November 21, 2023
Phase: Phase 4
Study type: Interventional

This study aims to conduct a multicenter, prospective, randomized clinical trial to scientifically evaluate the safety and efficacy of different perioperative sedation methods during endovascular thrombectomy in acute ischemic stroke patients with large vessel occlusion in the anterior circulation.

NCT ID: NCT06138210 Recruiting - Clinical trials for Acute Ischemic Stroke

The Effect of GD-iExo-003 in Acute Ischemic Stroke

ExoCURE
Start date: May 27, 2024
Phase: Phase 1
Study type: Interventional

This is a multicenter, randomized, double-blinded, placebo-controlled, dose-escalation trial. The objective of this study is evaluating safety and preliminary efficacy of intravenous exosomes derived from human induced pluripotent stem cell (GD-iExo-003) in acute ischemic stroke.

NCT ID: NCT06135103 Recruiting - Ischemic Stroke Clinical Trials

Phase 2 Study of TXA127 in Post-ischemic Stroke Patients

Start date: November 26, 2023
Phase: Phase 2
Study type: Interventional

This is a 50-patient, Phase 2, double-blind, randomized, placebo-controlled, hybrid decentralized study to evaluate the safety and efficacy of daily subcutaneous (SC) injection of TXA127 in post-ischemic stroke patients. Subjects will receive either TXA127 0.5mg/kg or placebo for 12 weeks started 6 to 24 months post ischemic stroke, and they will have a 12 week follow up visit after treatment has ended. The primary efficacy outcome measure is individual patient absolute change from baseline in motor and sensory functions as measured by the Fugl-Meyer Assessment of Upper Extremity (FMA-UE) 12 weeks after start of treatment.

NCT ID: NCT06134921 Recruiting - Ischemic Stroke Clinical Trials

Effects of Transcranial Electrical Stimulation in Stroke Individuals

Start date: November 15, 2023
Phase: N/A
Study type: Interventional

The present study will use transcranial electrical stimulation (tES) with conventional physical therapy in sub-acute (at least 2 weeks after stroke onset) to chronic stroke within 2 years to investigate the effect on cortical activity and upper and lower limb motor function. The findings may support the usage of tES for improving brain activity and motor function in a clinic setting.

NCT ID: NCT06134739 Recruiting - Atrial Fibrillation Clinical Trials

Arterial Embolism After Catheter Ablation of Atrial Fibrillation. ATRIAL FIBRILLATION

EMBOL-AF
Start date: January 2, 2024
Phase:
Study type: Observational

The EMBOL-AF is a multicenter, international, observational study designed as a retrospective registry that will investigate the characteristics of systemic arterial embolic events after treatment of atrial fibrillation by catheter ablation. Due to the retrospective nature of the study, the registry is specially focused on cerebral embolism (stroke and TIA) because these are not only the most frequent and clinically relevant but also the most susceptible to underreporting. However, all embolism associated to AFAbl will be included. This study will gather all clinically relevant aspects and data of all cases of arterial embolism that have occurred over the last 5 years in the centers that will participate in the registry. Based on these reported cases, the incidence, management and outcomes of embolic events (particularly stroke and TIA) will be studied.

NCT ID: NCT06133179 Recruiting - Cerebral Stroke Clinical Trials

Super-Resolution Ultrasound of the Brain in 3D

ESRC3D
Start date: March 22, 2024
Phase: N/A
Study type: Interventional

The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery. To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).

NCT ID: NCT06131827 Recruiting - Chronic Stroke Clinical Trials

Neural Mobilization With Task Based Activities on Upper Limb in Patients With Chronic Stroke.

Start date: July 17, 2023
Phase: N/A
Study type: Interventional

Stroke is defined as sudden neurological disruption of blood supply to brain. It is most common disease that causes severe disabilities like hemiparesis which is most common motor impairment that leads to persistent upper limb dysfunction. In this study we use two techniques to improve upper limb motor dysfunction and reduce spasticity. One is task-based activities which is used to improve motor function and focus on active participation rather than normal movement pattern and other is neural mobilization which aims to reduce spasticity which is most common in stroke patients.