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Stroke, Acute clinical trials

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NCT ID: NCT01957774 Completed - Stroke, Acute Clinical Trials

THR-18's Pharmacokinetics and Pharmacodynamics in Subjects With Acute Ischemic Stroke Treated With tPA

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test the experimental drug "THR-18" given together with the drug "tissue plasminogen activator" for the treatment of stroke. Tissue plasminogen activator is also called "tPA". Strokes often result from blockade of blood supply caused by blood clots forming within the blood vessel feeding the brain. Such strokes are called "Ischemic strokes". Treatment of these strokes is aimed at breaking up the blood clot(s) and renewing the blood flow before further parts of the brain die. Breaking up the blood clot is possible with the drug tPA when it is injected into a vein shortly after the stroke starts. However, along with breaking up the blood clot, tPA sometimes causes adverse effects, for example, it may cause bleeding. THR-18, the drug tested in this study, is meant to bind to tPA and reduce its adverse effects without stopping tPA's breaking up of the blocking blood clot. The primary purpose of this study is to evaluate the safety of THR-18 in acute ischemic stroke patients who are treated in parallel with tPA. Another purpose of this study is to investigate levels of THR-18 and tPA in the blood stream at different time points after they are injected, at the same time, into a vein. In addition, this study will measure tPA's effect on blood clot dissolution when tPA is given with and without THR-18. The study will also study the effect THR-18 may have on signals of brain damage that can be found in the blood after stroke: these signals of brain damage are small proteins called S100B and matrix metalloproteinase (MMP)-9. These proteins are released into the blood stream when the brain is injured. The safety evaluation of THR-18 in this study will be done in comparison to placebo. Placebo is a drug that looks exactly like THR-18 but has no activity. Three doses of THR-18 will be tested, one after the other, in three groups of patients. In each group, some patients will receive THR-18 and some will receive placebo. This clinical study will be conducted only at one hospital in the Ukraine. In total, 30 patients are planned to participate in this study. These patients will be in the hospital for at least 3 days after receiving the study treatment. Then, about 1 month later, they will be invited for a last follow-up visit.

NCT ID: NCT01705353 Terminated - Stroke, Acute Clinical Trials

The Role of HMGB-1 in Chronic Stroke

Start date: September 2012
Phase: N/A
Study type: Observational

The purpose of this study is to measure the presence of HMGB-1 and other proteins in the blood across five time points after stroke, and to determine if their presence correlates with rate of stroke recovery.

NCT ID: NCT01614080 Completed - Stroke, Acute Clinical Trials

Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA

OPHELIE
Start date: November 2011
Phase: N/A
Study type: Observational

intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).

NCT ID: NCT01600235 Recruiting - Stroke, Acute Clinical Trials

Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)

Start date: June 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke. The investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.

NCT ID: NCT01585597 Completed - Stroke, Acute Clinical Trials

Reperfusion With Cooling in Cerebral Acute Ischemia

ReCCLAIM
Start date: May 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).

NCT ID: NCT01582620 Terminated - Stroke, Acute Clinical Trials

Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals

Telestroke
Start date: August 2011
Phase: N/A
Study type: Interventional

The purpose is to study the clinical, technological and organizational impacts of a telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in Lofoten and Vesterålen. The stroke specialist in Bodø will examine the patient in cooperation with the doctor at the local hospital through video- and sound communication. Radiology images are transmitted using the RIS/PACS system. Telestroke consultations may be useful to assess whether the patient needs thrombolysis medication, and also whether there is a need for more advanced specialist neurological or neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit. The study design is a multi-method approach using before-and-after hospital information data as well as registration forms monitoring patient outcome and pathways. The research questions will be approached from medical, organisational and technological perspectives. A telestroke service in North Norway is expected to face other challenges than those reported internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is low, clinicians have high turnover, technical support is not available 24/7 and severe weather conditions and long distances might add to the transport time. Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and proper treatment Secondary hypothesis: Telestroke leads to improved overall patient treatment

NCT ID: NCT01581502 Active, not recruiting - Atrial Fibrillation Clinical Trials

SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)

SAMURAI-NVAF
Start date: September 2011
Phase: N/A
Study type: Observational

The purpose of this study is to determine choice of anticoagulant therapy during acute and chronic stages of ischemic stroke/TIA and short- and long-term outcomes, including stroke recurrence and bleeding complications, in patients having nonvalvular atrial fibrillation.

NCT ID: NCT01429597 Withdrawn - Stroke, Acute Clinical Trials

Fabry and Cardiomyopathy (FaCard)

FaCard
Start date: July 1, 2011
Phase:
Study type: Observational

Primary objective and endpoint is the analysis of the long-term course of lyso-Gb3 and its clinical correlation to the progression of the cardiomyopathy in N215S-Fabry patients.

NCT ID: NCT01400256 Withdrawn - Stroke, Acute Clinical Trials

Blood Pressure Lowering in Acute Stroke Trial

BLAST
Start date: August 2007
Phase: Phase 4
Study type: Interventional

The investigators hope to show that valsartan can be used safely in the setting of acute stroke to lower elevated blood pressure. There are novel properties of this class of drug (an angiotensive-receptor blocker or ARB), and promising human and animal data, that would suggest this drug can be safely used to lower blood pressure in the setting of acute stroke without compromising brain blood flow (i.e. cerebral perfusion). If this is proved to be the case, this compound could potentially be used routinely in this setting, with the hope of improving outcome. This pilot study may pave the way for a larger randomized trial looking at outcome measures in stroke patients. Further, a positive result in the this pilot study will serve as proof of concept that ARBs maintain cerebral perfusion while decreasing blood pressure, an overall favorable property.

NCT ID: NCT01327989 Active, not recruiting - Stroke, Acute Clinical Trials

Solitaire FR Thrombectomy for Acute Revascularisation

STAR
Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this observational clinical evaluation is to evaluate the safety and efficacy of the Solitaire FR Device in subjects requiring mechanical thrombectomy when used according to its Instruction For Use (IFU), in real life practice.