Welcome to the WSC 2022 Interactive Program

Background and Aims

Brain parenchymal perfusion imaging (CTP or MRI) can show potentially salvageable brain tissue beyond 4.5 hours of symptom onset in acute ischemic stroke (AIS) patients. In patients with AIS caused by large vessel occlusion (LVO) treated in the extended time window, with CTP selection, better outcomes were obtained with tenecteplase (TNK) versus tPA regarding arterial reperfusion and clinical outcomes. Other studies showed similar results comparing TNK to tPA. As a bolus-administered drug, TNK is more easy-to-use and even cheaper in some scenarios. None of these trials compared TNK in non-LVO AIS in the extended time window.

Methods

Prospective, multi-center, randomized, controlled, double-blinded trial with an adaptive design and population enrichment. The randomization employs a 1:1 ratio of intravenous thrombolysis with tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from the time last seen well (TLSW) and have evidence of salvageable brain tissue on perfusion imaging. The primary outcome will be the distribution of the modified Rankin Scale scores at 90 days (shift analysis) as evaluated by two separate assessors at the central core lab, with local reading as a backup mechanism.

Results

The study recruitment is ongoing, with the first interim analysis planned for mid-2023, including 386 patients with completed 90-days follow-up. The full estimated sample size is 642 patients.

Conclusions

The RESILIENT EXTEND-IV trial may provide inputs on the efficacy and safety of TNK use in non-LVO AIS in the extended time window
Tenecteplase/Placebo donated by Boehringer Ingelheim. This research is
funded through the Program of Institutional Development of the Brazilian Unified Health System (PROADI-SUS).

Background and Aims

Recent trials provided insight into the use of direct mechanical thrombectomy (without previous thrombolytic administration) as a non-inferior and safer alternative of treatment for patients with acute ischemic stroke (AIS) caused by large vessel occlusion (LVO). Furthermore, Other trials have suggested that IV tenecteplase (TNK), when administered before MT in LVO AIS patients, results in higher recanalization rates and better clinical outcomes compared to IV alteplase (tPA). None of these trials, however, have compared direct MT to TNK plus MT.

Methods

Randomized, prospective, multicenter, placebo-controlled clinical trial in patients with AIS due to LVO of the anterior circulation. Randomization will be 1:1 according to reperfusion treatment modalities: (A) direct mechanical thrombectomy (MT) – after placebo – vs. (B) Intravenous thrombolysis with TNK (0.25 mg/kg) plus MT. Randomization will be done by a minimization process using age (≤70 vs. >70 years), baseline National Institute of Health Stroke Scale (NIHSS) score (6-16 vs. 17 or more), time to IV treatment (<3 hours vs. 3-4.5 hours), and occlusion site (MCA-M1 vs. MCA-M2). The primary outcome will be the ordinal distribution from the modified Rankin scale score (mRS) 90 days after the randomization.

Results

The study recruitment is ongoing, with the first interim analysis planned for mid-2023, including 265 patients with completed 90-days follow-up. The full estimated sample size is 530 patients.

Conclusions

The RESILIENT DIRECT-TNK trial will provide evidence to decide between bridging with TNK or direct MT for AIS due to LVO.
Tenecteplase/Placebo donated by Boehringer Ingelheim. Thrombectomy devices donated by Medtronic. This research is funded through the Program of Institutional Development of the Brazilian Unified Health System (PROADI-SUS).

Background and Aims

The role of antiepileptic therapy in primary prevention of post stroke seizures is an important clinical dilemma in the field of stroke. Two Cochrane systematic reviews on arterial and venous stroke each, have concluded that there is insufficient evidence for or against prophylactic antiepileptic therapy. The main aim of this RCT is to find out whether prophylactic levetiracetam can prevent post stroke seizures in patients with arterial and venous stroke patients with cortical involvement.

Methods

PROLEVIS is an investigator-initiated, multi-centre, prospective, randomized, double blind, placebo controlled superiority trial which will enroll 800 patients (400 ischemic stroke and intracranial hemorrhage each, 1:1 allocation using permuted block randomisation, 200 in active arm and 200 in placebo arm). Eligibility will require a diagnosis of ischemic stroke, or parenchymal intracerebral hemorrhage (spontaneous non-aneurysmal, nontraumatic intracerebral hemorrhage) with a cortical syndrome (either parenchymal involvement documented by imaging or presence of aphasia, apraxia, agnosia or cortical visual disorders). Ischemic stroke patients must have a SELECT score of 2-6 and Intracranial Hemorrhage patients must have a CAVE score of 1-3. Recruitment should happen within 1 week of onset in ischemic stroke or intracranial hemorrhage. Patients will be randomized to either oral levetiracetam or placebo twice a day for 3 months.

Results

The primary outcome measure will be occurrence of first post stroke seizure. We have recruited 120 patients into this ongoing trial.

Conclusions

The results could have a major influence in the clinical practice regarding prophylactic antiepileptic therapy to stroke patients.

Funding: DST-SERB, Government of India

Background and Aims

Stroke has an important social and economic impact worldwide. Low and middle-income countries are particularly affected by the high costs of new technologies and treatments related to acute and post-acute stroke and increased indirect costs associated with loss of productivity, caregiver expenses, and institutionalization.

The study aims to assess the real-world costs and outcomes of acute ischemic stroke treatment through accurate costing methods, validate a standard set to drive the cost data collection and outcomes among the acute ischemic stroke care pathway across different countries, and determine the cost-effectiveness of acute ischemic stroke treatment strategies in the same country.

Methods

This is an economic evaluation, and data from stroke patients hospitalized from October 2021 to October 2022 will be collected through accurate costing methods and a standardized data spreadsheet. Approximately 10 high-volume stroke hospitals in Latin America will participate. Cost-effectiveness analysis will be performed to compare different treatment strategies in selected centers in the same country.

Results

Data collection has recently been initiated. We expect to present the final results during the 2022 World Stroke Congress.

Conclusions

The results could contribute to better allocating and optimizing resources and implementing treatment strategies to improve patients’ outcomes in the stroke care pathway. We also expect that this study could potentially encourage changes in National Health Policies, reducing the costs and the morbimortality of stroke in Latin America.

Background and Aims

Cardioembolic stroke accounts for more than 20% of all acute ischemic strokes (AIS) and is caused mainly by cardiac arrhythmias, predominantly atrial fibrillation (AF). Coexistence of one specific or multiple additional vascular risk factors constitute an indication for oral anticoagulant (OAC) therapy in patients with AF. Although OAC treatment reduces the risk of AIS by more than 80% in this group, it is still significantly higher comparing to general population. Unfortunately, about half of patients with AF on OAC treatment developing AIS would not meet criteria neither for thrombolytic (intravenous rtPA), nor mechanical thrombectomy (MT) treatment (high blood anticoagulant activity or non-large vessel occlusion stroke). The aim of STROACT study is to develop the first causative (reperfusion) therapy for this group of patients.

Methods

AIS patients treated with selected OACs (anti-IIa or anti-Xa activity > 50 ng/ml) and not eligible for MT, will receive reperfusion therapy with the following scheme: 1) Fast-acting antidote to reverse the effect of the particular OAC (for patients receiving rivaroxaban or apixaban: intravenous andexanet alfa; for patients receiving dabigatran: intravenous idarucizumab); 2) Intravenous thrombolytic therapy with rtPA. Each of the three arms of the study (AIS patients treated with rivaroxaban, apixaban, or dabigatran) has a prospective, randomized, placebo controlled interventional design and meets the criteria of a phase II trial.

Results

The primary endpoints: 1) regarding efficacy- modified Rankin Scale score 90 days after stroke onset; 2) regarding safety- mortality and rate of intracranial hemorrhages.

Conclusions

Final results of STROACT study are expected in 2025.

Background and Aims

Ischemic stroke has a large impact on cognitive performance and functional independence. Mainly, working memory and instrumental activities of daily living. Thus, several interventions have been developed to improve performance in daily living activities. However, the effects of working memory training on working memory are still scarce and arguable. The aim of this study was to determine the effect of a working memory training on instrumental activities of daily living and working memory performance compared to a standard intervention in a ischemic stroke population from a clinical facility in Colombia.

Methods

This was an experimental Randomized Clinical trial study with experimental and active control group. Both groups were assessed with a sociodemographic interview, the montreal cognitive assessment and the yesavage geriatric depression scale. Primary outcomes were assessed with the Lawton-Brody instrumental activities of daily living scale and the working memory questionnaire. Secondary outcomes were assessed with the working memory index and the corsi tapping task

Results

The main findings suggest significant differences among both groups in working memory tasks (near transfer effects) with higher effect sizes in the experimental group when compared with the active control group. However no differences were found in instrumental activities of daily living (far transfer effects)

Conclusions

However, intra-group effect sizes were large (>1.0) which implied better functional independence for activities like taking a phone call in the active control group. The experimental group also improved functional independence in activities like shopping and taking medications. These improvements are due to adjusting the level of difficulty os the tasks.

Background and Aims

To study the effect of continuous intracranial pressure monitoring-oriented comprehensive nursing on consciousness, limb function recovery, and complications in critically ill stroke patients.

Methods

A total of 120 patients with severe stroke treated in our hospital from January 2020 to December 2021 were selected. 120 patients with severe stroke were randomly divided into a study group (n=60) and a control group (n=60). Routine nursing was performed in the control group. The study group conducted comprehensive nursing guided by continuous intracranial pressure monitoring based on routine nursing. The incidence of short-term poor prognosis and the incidence of poor prognosis were studied before or 24 hours after admission.

Results

After nursing, the incidence of poor short-term prognosis and poor prognosis in the study group was lower than that in the control group (p<0.05). After 24 hours of nursing, the GCS score of the study group was higher than that of the control group (p<0.05). The incidence of complications in the study group was lower than that in the control group (p<0.05).

Conclusions

The application value of comprehensive nursing guided by continuous intracranial pressure monitoring in severe stroke patients is more significant. It is more beneficial to improve the degree of nerve defect, reduce the incidence of poor prognosis, improve patients' consciousness and the incidence of complications. Additionally, it can promote the recovery of limb function and the nursing satisfaction of patients as well.

Background and Aims

India has a severe shortage of specialists in rural areas with one of the world’s lowest physician/population ratios. Two innovative solutions include training physicians in district hospitals to diagnose and manage acute stroke (‘Stroke physician model’) and using a low‑cost Telestroke model. We will be assessing the efficacy of these models through a cluster‑randomized trial with a standard of care database maintained simultaneously in tertiary nodal centers with neurologists.

Methods

SMART INDIA is a multicenter, open‑label cluster‑randomized trial with the hospital as a unit of randomization. We plan to enroll 22 district hospitals where a general physician manages the emergency without the services of a neurologist. These units (hospitals) will be randomized into either of two interventions using computer‑generated random sequences with allocation concealment. The outcome will be assessed by a blinded, central adjudication team. The study includes 12 nodal centers involved in the Telestroke arm by providing neurologists and telerehabilitation round the clock for attending calls. There will be a preintervention data collection (1 month), followed by the intervention model implementation (3 months).

Results

The primary outcome will be the composite score (percentage) of performance of acute stroke care bundle assessed at 1 and 3 months after the intervention. The highest score (100%) will be achieved if all the eligible patients receive the standard stroke care bundle.

Conclusions

SMART INDIA assesses whether the low‑cost Telestroke model is superior to the stroke physician model in achieving acute stroke care delivery in resource limited settings.

Funding: DHR, ICMR, Government of India

Background and Aims

Atrial fibrillation (AF) is one of the most frequent causes of stroke. We aim to evaluate whether a risk-adapted intensified heart rhythm monitoring with consecutive initiation of oral anticoagulation leads to a reduction of cardioembolism (recurrent ischemic stroke or systemic embolism)

Methods

Find-AF 2 is a randomized and controlled open-label parallel multicenter trial with blinded endpoint assessment. 5,200 patients ≥ 60 years with symptomatic ischemic stroke within the last 30 days and without known AF nor (contra-)indications for OAC will be included at approximately 50 study centers in Germany. Patients without AF in a 24-hour Holter-ECG will be randomized in a 1:1 fashion to either enhanced, prolonged and intensified ECG-monitoring (intervention arm) or standard of care (control arm). In the intervention arm, patients with a high risk of underlying AF will receive continuous rhythm monitoring using an implantable cardiac monitor (ICM) whereas those without high risk of underlying AF will receive repetitive 7-day Holter-ECGs. Patients will be followed for at least 24 months. The primary efficacy endpoint is the time until recurrent ischemic stroke or systemic embolism.

Results

52 of 53 planned study sites are open. Between JUL-2020 and APR-2022, 1,974 patients have been enrolled and 1,864 patients have been randomized. We expect recruitment to be finished by February 2024 and the last follow-up visit will be in February 2026. We expect results of the trial to be presented in the second half of 2026.

Conclusions

Find-AF 2 will provide randomized evidence whether rhythm monitoring leads to a reduction in cardioembolism

Background and Aims

Despite recent scientific advances in acute ischemic stroke treatment, there has been limited progress for the secondary prevention of cryptogenic ischemic stroke. The present proposed study is designed for evaluation of efficacy and safety of rivaroxaban plus aspirin in reducing stroke recurrence in patients with embolic stroke of undetermined source (ESUS).

Methods

This is a randomized, parallel-group, outcome assessor blind, placebo-controlled study on the recent (7-60 days) ESUS patients identified only one risk factor of potential embolic source including: 1-PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s 2-LVH in standard ECG( Sokolow index≥ 35 mm) or echocardiography 3-Moderate or severe MR, AR or AS on echocardiography 4-left atrium enlargement on echocardiography 5-PFO not candidate for closure. After meeting all inclusion and exclusion criteria patients (total 40 patients) will be randomized to rivaroxaban 2.5 mg BID plus ASA 80 mg daily or ASA 80 mg plus placebo (1:1 ratio) and will be visited every three months until one year. Any adverse events, serious side effects, outcome events will be recorded. The primary outcome is defined as the rate and time of stroke occurrence and major bleeding events.

Results

One year fallow up was completed for 29 patients (16 in rivaroxaban and 13 in placebo group). Only in one patient of placebo group, ischemic stroke recurred. No major bleeding event occurred in both groups.

Conclusions

Low dose rivaroxaban plus aspirin is expected to be a safe and effective for prevention of recurrence in ESUS.