- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion date, Trial withdrawal, Trial primary completion date: Surgical Stabilizer Assisted RVC With rtPA for CRVO (clinicaltrials.gov) - Aug 29, 2022
P1, N=0, Withdrawn,
Trial completion date: May 2017 --> Dec 2021 | Completed --> Withdrawn | Trial primary completion date: Apr 2017 --> Dec 2021
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: A Nursing Approach to Improving Critical Care Compliance With Vital Signs and Neurological Assessments in Post-IV-Alteplase Stroke Patients. (Pubmed Central) - Aug 28, 2022
This article outlines a nursing intervention regarding the use of intravenous thrombolytic therapy for treating acute ischemic stroke, the risk factors related to IV-alteplase, best-practice protocols, and the nursing role in efforts to deliver safe care. The conclusion reveals the need for health care organizations to explore opportunities, continually inspire innovation at the bedside, highlight nursing's essential contribution to acute stroke care, and encourage publishing improvements in patient care and the nurse practice environment.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Effect of Salvia Miltiorrhiza Polyphenolic Acid Injection on Improving Limb Use and Cognitive Impairment in Patients with Acute Stroke. (Pubmed Central) - Aug 28, 2022
The clinical data of 90 acute stroke patients were collected for retrospective study and divided into 45 cases each in the comparison group and the observation group according to the different treatment methods; using basic treatment + salvianolic acid, the comparison group implemented conventional alteplase and butalbital treatment, and the observation group used injectable salvianolic acid treatment, to observe and compare the clinical efficacy, changes in neurological deficits, cognitive function, and motor function scores before and after treatment in the two groups...There was no statistically significant difference in liver and kidney function and cardiac enzyme test indexes between the two groups of patients at 14 days of treatment (P > 0.05). Danshen polyphenolic acid for injection has definite clinical efficacy in the treatment of acute ischemic stroke, and it can effectively improve cognitive and motor functions and promote neurological recovery in patients with high safety.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Major Bleeding Postadministration of Tenecteplase Versus Alteplase in Acute Ischemic Stroke. (Pubmed Central) - Aug 26, 2022
There was no significant difference in all-cause inpatient mortality for alteplase versus tenecteplase (10 [5%] vs 5 [4%], P = 0.934) or in adverse events between the groups (22 [9%] vs 14 [12%], P = 0.541) for alteplase and tenecteplase, respectively. Tenecteplase had similar rates of major bleeding versus alteplase and may be a reasonable alternative in the treatment of acute ischemic stroke.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
PK/PD data, Retrospective data, Journal: Acute ischemic stroke on anti-Xa inhibitors: Pharmacokinetics and outcomes. (Pubmed Central) - Aug 25, 2022
Patients with AIS on DOAC therapy face a heightened risk of mortality. Studies are needed to investigate the safety and efficacy of thrombolysis in such patients based on time of last DOAC ingestion and/or anti-Xa/drug level.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion date, Trial primary completion date: Intrapleural Fibrinolytic Therapy to Enhance Chemical Pleurodesis Enhance Chemical Pleurodesis (clinicaltrials.gov) - Aug 24, 2022
P4, N=136, Recruiting,
Studies are needed to investigate the safety and efficacy of thrombolysis in such patients based on time of last DOAC ingestion and/or anti-Xa/drug level. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Oct 2022 --> Jun 2023
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim
Journal: IV thrombolysis with tenecteplase for the treatment of acute ischemic stroke. (Pubmed Central) - Aug 24, 2022
IVT with tenecteplase was associated with better 3-month clinical outcomes compared to IVT with alteplase in AIS patients, with no increased risk of symptomatic intracranial bleeding. ANN NEUROL 2022;92:349-357.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion date, Trial primary completion date: FIVHeMA: Intraventricular Fibrinolysis for Aneurysmal Subarachnoid Hemorrhage. (clinicaltrials.gov) - Aug 24, 2022
P3, N=440, Recruiting,
ANN NEUROL 2022;92:349-357. Trial completion date: Mar 2023 --> Jan 2025 | Trial primary completion date: Oct 2022 --> Jul 2024
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: IV tenecteplase: A non-inferior alternative to alteplase? (Pubmed Central) - Aug 22, 2022
The standard medical therapy for intravenous thrombolysis in patients with stroke presenting within 3 h is alteplase, a tissue plasminogen activator. Menon and colleagues assessed the non-inferiority, efficacy, and safety of tenecteplase, a modified version of alteplase, in patients with acute ischemic stroke presenting within 4.5 h of onset.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Anaphylaxis After Alteplase During Treatment of Pulmonary Embolism (Zone 4, Science and Technology Hall, Level 200) - Aug 20, 2022 - Abstract #AHA2022AHA_6117;
Menon and colleagues assessed the non-inferiority, efficacy, and safety of tenecteplase, a modified version of alteplase, in patients with acute ischemic stroke presenting within 4.5 h of onset. Abstract is embargoed at this time.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Review, Journal: Tenecteplase or Alteplase: What Is the Thrombolytic Agent of the Future? (Pubmed Central) - Aug 17, 2022
Based on recent and upcoming trials, guidelines may soon recommend tenecteplase as a suitable alternative to alteplase. The use of tenecteplase in specific subgroups will depend on further recruitment to ongoing clinical trials.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Asymmetric Contralateral Angioedema After Alteplase Administration For Ischemic Stroke (Hall C) - Aug 15, 2022 - Abstract #ASA2022ASA_2381;
Asymmetric angioedema is a rare but potentially life-threatening complication of tPA administration associated with prior ACE inhibitor therapy. While cases usually respond to more conservative measures, some patients may require more urgent airway intervention in rare instances.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, Journal: Outcomes After Endovascular Thrombectomy With or Without Alteplase in Routine Clinical Practice. (Pubmed Central) - Aug 12, 2022
However, alteplase treatment was associated with higher risk of sICH (6.5% [685 of 10 530 patients] vs 5.3% [279 of 5249 patients]; OR, 1.28; 95% CI, 1.16-1.42; P < .001). In this observational cohort study of patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes but higher sICH risk after adjusting for other covariates.
- |||||||||| Review: The Efficacy and Safety of Ischemic Stroke Therapies: An Umbrella Review. (Pubmed Central) - Aug 10, 2022
Our study demonstrated that tPA, edaravone and tPA, tPA and MTE, acupuncture and Western medicines, and blood-activating and stasis-dispelling herbs with Western medicines are the optimum neurological function and activities of daily living medication for patients with ischemic stroke. Systematic Review Registration: https://inplasy.com/, identifier [INPLASY202250145].
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Review, Journal: Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism. (Pubmed Central) - Aug 9, 2022
The included trial compared ultrasound-augmented catheter-directed thrombolysis with alteplase and systemic heparinisation versus systemic heparinisation alone...Researchers should consider clinically relevant primary outcomes (e.g. mortality and exercise tolerance), rather than surrogate markers (e.g. right ventricular to left ventricular (RV:LV) ratio or thrombus burden), which have limited clinical utility. Trials must include a control group to determine if the effects are specific to the treatment.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: TRISTARDS: A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19 (clinicaltrials.gov) - Aug 8, 2022
P2b/3, N=104, Terminated,
Trials must include a control group to determine if the effects are specific to the treatment. N=320 --> 104 | Trial completion date: Aug 2023 --> Jul 2022 | Recruiting --> Terminated | Trial primary completion date: Jun 2023 --> Jul 2022
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, Retrospective data, Journal: Methodological survey of missing outcome data in an alteplase for ischemic stroke meta-analysis. (Pubmed Central) - Aug 6, 2022
This methodological survey of an alteplase for ischemic stroke meta-analysis revealed MOD may be an important source of unrecognized bias. This survey highlights the need for sensitivity analyses using more robust methods of imputation.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Nonimmunogenic staphylokinase in the treatment of acute ischemic stroke (FRIDA trial results) (Pubmed Central) - Aug 6, 2022
It has been shown that a single bolus (within 10 s) administration of NS at a standard dose of 10 mg, regardless of body weight, allows to conduct fast, effective and safe thrombolytic therapy in patients with IS within 4.5 h after symptom onset. In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Alteplase for ischemic stroke: A giant with feet of clay? (Pubmed Central) - Aug 4, 2022
In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS. No abstract available
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Carotid Web as an Embolic Source of Acute Ischemic Stroke. (Pubmed Central) - Aug 4, 2022
No randomized, controlled prospective studies have compared the efficacy of endarterectomy to carotid artery stenting in patients with symptomatic carotid web. This case emphasizes the importance of considering carotid web as an embolic source of stroke in the young and provides support for revascularization as a safe and effective mean of secondary stroke prevention.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion: ARAMIS: Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke (clinicaltrials.gov) - Aug 3, 2022
P4, N=760, Completed,
This case emphasizes the importance of considering carotid web as an embolic source of stroke in the young and provides support for revascularization as a safe and effective mean of secondary stroke prevention. Recruiting --> Completed
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Preclinical, Journal: Novel Ex-Vivo Thrombolytic Reconditioning of Kidneys Retrieved 4 to 5 Hours after Circulatory Death. (Pubmed Central) - Jul 30, 2022
Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials. Kidneys from extended uDCD, not receiving aCPR/EC, can be salvaged using thrombolytic treatment to remove fibrin thrombi while preserving histology and enabling transplantation with a clinically acceptable early function.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, Journal: By and Large, Thrombectomy in Large Core Is a Palpable Reality. (Pubmed Central) - Jul 29, 2022
Another limitation is the lack of benefit when using the traditional metric-modified Rankin Scale score 0-2. We consider the results of RESCUE-Japan LIMIT encouraging and a clear motivation to continue and complete other studies.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Enrollment closed, Real-world evidence, Real-world: Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients (clinicaltrials.gov) - Jul 28, 2022
P=N/A, N=2500, Active, not recruiting,
We consider the results of RESCUE-Japan LIMIT encouraging and a clear motivation to continue and complete other studies. Not yet recruiting --> Active, not recruiting
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: One-Year Outcome Trajectories and Factors Associated with Functional Recovery Among Survivors of Intracerebral and Intraventricular Hemorrhage With Initial Severe Disability. (Pubmed Central) - Jul 26, 2022
This post hoc analysis pooled all individual patient data from the Clot Lysis: Evaluating Accelerated Resolution of Intraventricular Hemorrhage phase 3 trial (CLEAR-III) and the Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation (MISTIE-III) phase 3 trial in multiple centers across the US, Canada, Europe, and Asia...Hospital events were strongly associated with long-term functional recovery and may be potential targets for intervention. Avoiding early pessimistic prognostication and delaying prognostication until after treatment may improve ability to predict future recovery.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Observational data, Review, Journal: Comparison of tenecteplase versus alteplase in STEMI patients treated with ticagrelor: A cross-sectional study. (Pubmed Central) - Jul 23, 2022
The administration of tenecteplase in STEMI patients who received a loading dose with ticagrelor resulted in a significant reduction in MACE compared to alteplase. Larger multi-center studies are warranted to investigate the effect of tenecteplase treatment on clinical results.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal, Head-to-Head: Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial. (Pubmed Central) - Jul 23, 2022
P3
In safety analyses, 27 (3·4%) of 800 patients in the tenecteplase group and 24 (3·2%) of 763 in the alteplase group had 24 h symptomatic intracerebral haemorrhage and 122 (15·3%) of 796 and 117 (15·4%) of 763 died within 90 days of starting treatment Intravenous tenecteplase (0·25 mg/kg) is a reasonable alternative to alteplase for all patients presenting with acute ischaemic stroke who meet standard criteria for thrombolysis. Canadian Institutes of Health Research, Alberta Strategy for Patient Oriented Research Support Unit.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Case Report: Possible Serotonin Syndrome in a Patient Taking Kratom and Multiple Serotonergic Agents. (Pubmed Central) - Jul 17, 2022
• Reperfusion, serum glucose, ASPECTS, CBS, collateral score, and the pass number of thrombectomy device were associated with the occurrence of mMCAi after EVT in stroke patients. Because substances contained in kratom can inhibit metabolism of prescription serotonergic medications, clinicians must be aware of potential development of serotonin syndrome.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Preclinical, Journal: Long-term Transplant Function After Thrombolytic Treatment Ex Vivo of Donated Kidneys Retrieved 4 to 5 Hours After Circulatory Death. (Pubmed Central) - Jul 15, 2022
Our results do not support the use of these metrics to guide IVT treatment decisions prior to EVT in comprehensive stroke centres. The present method salvages kidneys from extended unontrolled donation after circulatory death using thrombolytic treatment while preserving histology and enabling transplantation after ex vivo reconditioning, with clinically acceptable late function after 3 mo, as measured by creatinine and iohexol clearance.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Investigational drugs for ischemic stroke: what's in the clinical development pipeline for acute phase and prevention? (Pubmed Central) - Jul 15, 2022
Regarding primary and secondary prevention, research is primarily focused on identifying mechanisms to improve the safety-efficacy profile using a "hemostasis-sparing" approach. Further evaluation on those agents that have already shown promise for their risk/benefit profiles, would benefit greatly a neurologist's capacity to successfully prevent and treat ischemic stroke patients.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, Journal, Head-to-Head: Endovascular thrombectomy versus standard bridging thrombolytic with endovascular thrombectomy within 4·5 h of stroke onset: an open-label, blinded-endpoint, randomised non-inferiority trial. (Pubmed Central) - Jul 13, 2022
P3
We did not show non-inferiority of direct endovascular thrombectomy compared with bridging therapy. The additional information from our study should inform guidelines to recommend bridging therapy as standard treatment.
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