- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, P3 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Efficacy and safety of minimally invasive surgery with thrombolysis in intracerebral haemorrhage evacuation (MISTIE III): a randomised, controlled, open-label, blinded endpoint phase 3 trial. (Pubmed Central) - May 2, 2019
P3
For moderate to large intracerebral haemorrhage, MISTIE did not improve the proportion of patients who achieved a good response 365 days after intracerebral haemorrhage. The procedure was safely adopted by our sample of surgeons.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Review, Journal: The role of endogenous tissue-type plasminogen activator in neuronal survival after ischemic stroke: friend or foe? (Pubmed Central) - Apr 28, 2019
Endogenous protease tissue-type plasminogen activator (tPA) has highly efficient fibrinolytic activity and its recombinant variants alteplase and tenecteplase are established as highly effective thrombolytic drugs for ischemic stroke...Then we focus on possible hypotheses about why and how endogenous tPA mediates ischemic neuronal death and survival. Finally, we analyze how endogenous tPA affects neuron fate in ischemic stroke in a comprehensive view.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Journal: Professional guideline versus product label selection for treatment with IV thrombolysis: An analysis from SITS registry. (Pubmed Central) - Apr 23, 2019
...If all patients were treated by ESO guidelines, an additional 17,031 would receive alteplase, which translates into 1922 more patients with favourable three-month outcomes...Closer alignment with professional guidelines would increase patients treated and favourable outcomes. Product labels should be revised to allow treatment of patients ≤4.5 h from onset and aged ≥80 years.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Journal: Drip and ship versus direct to endovascular thrombectomy: The impact of treatment times on transport decision-making. (Pubmed Central) - Apr 23, 2019
...It is unknown if bypassing thrombolysis centres in favour of endovascular thrombectomy (mothership) outweighs transport to the nearest thrombolysis centre for alteplase and then transfer for endovascular thrombectomy (drip-and-ship)...A moderate improvement in treatment times results in significant predicted changes to the optimisation of a national acute stroke patient transport strategy. Modelling patient transport for system-level planning is sensitive to treatment times at both thrombolysis and thrombectomy centres and has important implications for the future planning of thrombectomy services.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Clinical, Journal: Women on Hormone Therapy with Ischemic Stroke, Effects on Deficits and Recovery. (Pubmed Central) - Apr 23, 2019
...We included all women consults regardless of IV Alteplase treatment...The mRS scores at three months indicated significant improvements among HT users vs. non-HT use (1.46 ± 0.4 vs. 2.51 ± 0.2, p=0.05). While cautions persist on the use, route and dosage of HT for risks of ischemic stroke, the HT moderation of AIS deficits and outcomes in women <80 years of age warrants further investigation.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion date, Trial termination, Trial primary completion date: Thrombolysis in Ischemic Spinal Cord Stroke (clinicaltrials.gov) - Apr 20, 2019
P2, N=12, Terminated,
This experience may help guide the design of a randomized controlled trial to determine the safety and efficacy of low-dose alteplase for submassive pulmonary embolism. Trial completion date: Oct 2018 --> Mar 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2018 --> Mar 2019
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Preclinical, Journal: Alteplase and DNase for the treatment of pleural empyema in rats. (Pubmed Central) - Apr 18, 2019
Trial completion date: Oct 2018 --> Mar 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2018 --> Mar 2019 Alteplase, DNase and alteplase + DNase changed significantly physical and chemical properties of experimental empyema at fibrinopurulent phase: alteplase reduced molecular size larger than 135 nm and DNase reduced viscosity.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Journal: Minimally invasive surgery plus alteplase for intracerebral haemorrhage. (Pubmed Central) - Apr 16, 2019
Alteplase, DNase and alteplase + DNase changed significantly physical and chemical properties of experimental empyema at fibrinopurulent phase: alteplase reduced molecular size larger than 135 nm and DNase reduced viscosity. No abstract available
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Review, Journal: Telehealth for Remote Stroke Management. (Pubmed Central) - Apr 7, 2019
...We also present evidence that the safety and effectiveness of intravenous alteplase in community hospitals in a telestroke network seems to be comparable with that achieved in dedicated stroke centres...Telestroke networks can also be used for identification and enrollment of patients into emergency stroke trials and thus provide a more representative sample of the population and increase recruitment. Standardization of regional telestroke networks could lead to collaborations with larger data acquisitions for research purposes and quality control in the future.
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion: HaemInCor: Intramyocardial Haemorrhage in Patients With Primary STEMI (clinicaltrials.gov) - Apr 5, 2019
P=N/A, N=60, Completed,
Standardization of regional telestroke networks could lead to collaborations with larger data acquisitions for research purposes and quality control in the future. Recruiting --> Completed
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Clinical, Journal, HEOR: Cost-effectiveness of targeted thrombolytic therapy for stroke patients using multi-modal CT compared to usual practice. (Pubmed Central) - Apr 3, 2019
Recruiting --> Completed In a healthcare setting where multimodal imaging technologies are available and reimbursed, their use in screening patients presenting with acute stroke to determine eligibility for alteplase treatment is cost-effective given a range of willingness-to-pay thresholds and warrants consideration as an alternative to routine practice.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Journal: Thrombolysis: Improving door-to-needle times for ischemic stroke treatment - A narrative review. (Pubmed Central) - Mar 27, 2019
There are many exciting areas of future direction including reduction of door-to-needle time in developing countries, improving pre-hospital response times, and improving the efficiency of endovascular treatment. Conclusions There is now a broad understanding of the causes of delays to fast treatment and the strategies that can be employed to improve door-to-needle time such that most centers could achieve median door-to-needle time of 30 min.
- |||||||||| voriconazole / Generic mfg., Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, Journal, HEOR: Intensive care unit drug costs in the context of total hospital drug expenditures with suggestions for targeted cost containment efforts. (Pubmed Central) - Mar 21, 2019
Conclusions There is now a broad understanding of the causes of delays to fast treatment and the strategies that can be employed to improve door-to-needle time such that most centers could achieve median door-to-needle time of 30 min. Growth rates of costs per year have declined but still drug expenditures in the ICU are consistently a significant driver in this resource intensive environment with a high impact on hospital drug expenditures.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Hakko Kirin, Mitsubishi Tanabe
Clinical, P3 data, Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Intensive blood pressure reduction with intravenous thrombolysis therapy for acute ischaemic stroke (ENCHANTED): an international, randomised, open-label, blinded-endpoint, phase 3 trial. (Pubmed Central) - Mar 21, 2019
P3
These results might not support a major shift towards this treatment being applied in those receiving alteplase for mild-to-moderate acute ischaemic stroke. Further research is required to define the underlying mechanisms of benefit and harm resulting from early intensive blood pressure lowering in this patient group.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion, Trial completion date, Trial primary completion date: Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED) (clinicaltrials.gov) - Mar 6, 2019
P3, N=4587, Completed,
N=50 --> 350 Recruiting --> Completed | Trial completion date: Feb 2019 --> Aug 2018 | Trial primary completion date: Dec 2018 --> Aug 2018
- |||||||||| TNKASE (tenecteplase) / Roche, Boehringer Ingelheim, Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
New P3 trial: NOR-TEST 2: The Norwegian Tenecteplase Stroke Trial 2 (clinicaltrials.gov) - Feb 26, 2019
P3, N=1342, Not yet recruiting,
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion date, Trial initiation date, Trial primary completion date: Study of Sodium Bicarbonate in Restoring Blocked Catheters (clinicaltrials.gov) - Feb 4, 2019
P2, N=608, Not yet recruiting,
Recruiting --> Completed | Trial completion date: Feb 2019 --> Aug 2018 | Trial primary completion date: Dec 2018 --> Aug 2018 Trial completion date: Apr 2019 --> Aug 2021 | Initiation date: Oct 2018 --> Apr 2019 | Trial primary completion date: Oct 2018 --> Aug 2020
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial primary completion date: Intracranial Collaterals in Acute Stroke and Clinical Outcome (clinicaltrials.gov) - Jan 9, 2019
P=N/A, N=30, Recruiting,
Not yet recruiting --> Recruiting Trial primary completion date: Nov 2018 --> Feb 2019
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Clinical, Journal: Comparison of Stroke Outcomes of Hub and Spoke Hospital Treated Patients in Mayo Clinic Telestroke Program. (Pubmed Central) - Dec 13, 2018
The key findings were that evidence-based stroke thrombolysis eligibility decision making, thrombolysis administration, and thrombolysis emergency stroke metrics were uniformly excellent for the spoke hospital group when compared to the standard hub hospital group. However, evidence-based stroke hospitalization and discharge metrics were inferior for the spoke hospital group when compared to the standard hub hospital.
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion, Surgery: MISTIE III: Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III (clinicaltrials.gov) - Dec 12, 2018
P3, N=506, Completed,
However, evidence-based stroke hospitalization and discharge metrics were inferior for the spoke hospital group when compared to the standard hub hospital. Active, not recruiting --> Completed
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Enrollment open: ARAMIS: Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke (clinicaltrials.gov) - Oct 19, 2018
P4, N=760, Recruiting,
Initiation date: Sep 2018 --> Dec 2018 Not yet recruiting --> Recruiting
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion date, Trial initiation date, Trial primary completion date: Peripheral Systemic Thrombolysis Versus Catheter Directed Thrombolysis for Submassive PE (clinicaltrials.gov) - Oct 12, 2018
P4, N=158, Not yet recruiting,
Not yet recruiting --> Recruiting Trial completion date: Jul 2022 --> Dec 2022 | Initiation date: Jul 2018 --> Dec 2018 | Trial primary completion date: Jul 2021 --> Dec 2021
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion, Trial completion date, Trial primary completion date: Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke (clinicaltrials.gov) - Oct 12, 2018
P3, N=501, Completed,
Trial completion date: Jul 2022 --> Dec 2022 | Initiation date: Jul 2018 --> Dec 2018 | Trial primary completion date: Jul 2021 --> Dec 2021 Active, not recruiting --> Completed | Trial completion date: May 2018 --> Oct 2018 | Trial primary completion date: Mar 2018 --> Oct 2018
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Enrollment change, Trial completion date: INTRECIS: Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset (clinicaltrials.gov) - Oct 5, 2018
P=N/A, N=4000, Recruiting,
Active, not recruiting --> Completed | Trial completion date: May 2018 --> Oct 2018 | Trial primary completion date: Mar 2018 --> Oct 2018 N=3000 --> 4000 | Trial completion date: Aug 2019 --> Dec 2019
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Extending the Time for Thrombolysis in Emergency Neurological Deficits (clinicaltrials.gov) - Sep 1, 2018
P3, N=180, Completed,
N=3000 --> 4000 | Trial completion date: Aug 2019 --> Dec 2019 Active, not recruiting --> Completed | N=400 --> 180 | Trial completion date: Mar 2019 --> Aug 2018 | Trial primary completion date: Dec 2018 --> Aug 2018
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: EXTEND (International): Extending the Time for Thrombolysis in Emergency Neurological Deficits (International) (clinicaltrials.gov) - Sep 1, 2018
P3, N=45, Completed,
Active, not recruiting --> Completed | N=400 --> 180 | Trial completion date: Mar 2019 --> Aug 2018 | Trial primary completion date: Dec 2018 --> Aug 2018 Active, not recruiting --> Completed | N=200 --> 45 | Trial completion date: Mar 2019 --> Aug 2018 | Trial primary completion date: Dec 2018 --> Aug 2018
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Enhancing Donated After Cardiac Death (DCD) Utilization With Thrombolytic Therapy (clinicaltrials.gov) - Aug 29, 2018
P=N/A, N=103, Completed,
Active, not recruiting --> Completed | N=200 --> 45 | Trial completion date: Mar 2019 --> Aug 2018 | Trial primary completion date: Dec 2018 --> Aug 2018 Active, not recruiting --> Completed | N=50 --> 103 | Trial completion date: Dec 2017 --> May 2018 | Trial primary completion date: Dec 2017 --> Oct 2015
- |||||||||| Activase (alteplase) / Roche, Boehringer Ingelheim, Kyowa Kirin, Mitsubishi Tanabe
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: TOP-TRIAL Safety of Not Flushing Non-used PORT-A-CATH (clinicaltrials.gov) - Aug 21, 2018
P1, N=4, Terminated,
Active, not recruiting --> Completed | N=50 --> 103 | Trial completion date: Dec 2017 --> May 2018 | Trial primary completion date: Dec 2017 --> Oct 2015 N=60 --> 4 | Recruiting --> Terminated | Trial completion date: Jun 2019 --> Jul 2016 | Trial primary completion date: Nov 2018 --> Jul 2016; poor recruitment
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