Table 2.
Clinical trials targeting the related signaling pathways involved in corresponding pathophysiology in ischemic stroke
| Trial number | Trial name | Current Status | Study start and end date | Duration[y] | Phase | Sponsor | No.of participants | Type | Dose | Route | Time form stroke onset | Description (Signaling pathways) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00591084 | Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke | Compl | 2005–2006 | 1 | 2 | Hospital | 199 | ginsenoside-Rd | 10 or 20 mg/d | IV | <72 h | Ca2+channel blocker |
| NCT00815763 | Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke | Compl | 2006–2008 | 2 | 3 | Hospital | 390 | ginsenoside-Rd | 20 mg/d | IV | <72 h | Ca2+channel blocker |
| NCT02446977 | Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke | Compl | 2015–2015 | 1 | 2 | Hospital | 50 | CBG000592 | 20 mg/d | IV | <3 h | FMN,FAD |
| NCT02930018 | Safety and Efficacy of Nerinetide (NA-1) in Subjects Undergoing Endovascular Thrombectomy for Stroke | Compl | 2017–2019 | 2 | 3 | Industry | 1105 | NA-1 | 2.6 mg/kg | IV | <12 h | GluN2B-PSD95–nNOS interaction |
| NCT04462536 | Efficacy and Safety of Nerinetide in Participants With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy Excluding Thrombolysis | Recru | 2020–2022 | 2 | 3 | Industry | 1020 | NA-1 | 2.6 mg/kg | IV | <12 h | GluN2B-PSD95–nNOS interaction |
| NCT00728182 | Evaluating Neuroprotection in Aneurysm Coiling Therapy | Compl | 2008–2011 | 3 | 2 | Industry | 185 | NA-1 | 2.6 mg/kg | IV | <72 h | GluN2B-PSD95–nNOS interaction |
| NCT02315443 | Field Randomization of NA-1 Therapy in Early Responders | Recru | 2015–2022 | 7 | 3 | Industry | 558 | NA-1 | 2.6 mg/kg | IV | <3 h | GluN2B-PSD95–nNOS interaction |
| NCT02549846 | AdminiStration of Statin On Acute Ischemic stRoke patienT Trial | Compl | 2015–2017 | 2 | 4 | University | 270 | Atorvastatin Pitavastain Rosuvastatin | 20 mg/d 4 mg/d 5 mg/d | PO | <24 h | HMG-CoA Reductase Inhibitors |
| NCT04834388 | Studying Anakinra to Reduce Secondary Brain Damage After Spontaneous Haemorrhagic Stroke | Not Recru | 2021–2022 | 1 | 2 | University Hospital | 75 | anakinra | 100 or 500 mg | IV | <8 h | IL-1 system |
| NCT03737344 | BLOC-ICH: Interleukin-1 Receptor Antagonist in Intracerebral Haemorrhage | Compl | 2019–2021 | 2 | 2 | University/College | 25 | IL-1Ra Kineret® | 100 mg | SC | <8 h | IL-1 system |
| NCT02002390 | Efficacy and Safety of FTY720 for Acute Stroke | Compl | 2012–2014 | 2 | 2 | Hospital | 22 | Fingolimod | 0.5 mg | PO | <72 h | Inflammation |
| NCT04629872 | Fingolimod in Endovascular Treatment of Ischemic Stroke | Recruiting | 2020–2021 | 1 | 2 | University Hospital | 30 | Fingolimod | 0.5 mg | PO | <6–24 h | Inflammation |
| NCT04675762 | Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke | Recruiting | 2021–2022 | 1 | 2 | University Hospital | 118 | Fingolimod | 0.5 mg | PO | <24 h | Inflammation |
| NCT04419337 | Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Patients With Stroke | Recruiting | 2021–2023 | 2 | 3 | University Hospital | 550 | Metformin | / | PO | <3 months | Inflammation |
| NCT04069546 | The Efficacy of Remote Ischemic Conditioning on Stroke-induced Immunodeficiency | Compl | 2019–2020 | 1 | Not applicable | University | 46 | Remote ischemic conditioning | Physical strategy | Physical strategy | <48 h | Inflammation |
| NCT00376207 | Physical Activity After Stroke: How Does it Effect Chronical Inflammation and Insulin Sensitivity | Compl | 2006–2007 | 1 | Not applicable | Hospital | 200 | Physical exercise | / | Physical strategy | / | Inflammation |
| NCT02225834 | Atorvastatin in Acute Stroke Treatment | Compl | 2011–2014 | 3 | 4 | University | 50 | Atorvastatin | 80 mg | PO | <48 h | Inflammation |
| NCT00097318 | Safety Study of Interferon Beta 1a to for Acute Stroke | Compl | 2004–2011 | 7 | 1 | NIH Clinical center | 60 | rh IFN-Beta 1a | 11 mcg/22 mcg/44 mcg/66 mcg/88 mcg | PO | <24 h | Inflammation/BBB |
| NCT02878772 | Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients | Compl | 2014–2015 | 1 | 2,3 | University Hospital | 60 | Vinpocetine | 30 mg | PO | <48 h | Inflammation/NF-Kb |
| NCT01831011 | Mildronate for Acute Ischemic Stroke | Compl | 2008–2010 | 2 | 2 | Hospital | 227 | mildronate injection | 500 mg/d | IV | <7 days | inhibitor of carnitine-dependent metabolism |
| NCT04479449 | Efficacy and Safety of SP-8203 in Patients With Ischemic Stroke Requiring rtPA | Compl | 2019–2020 | 1 | 2 | Industry | 178 | SP-8203 | 80 mg/d | IV | <4.5 h | Matrix metalloprotease pathway |
| NCT02787278 | Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA | Compl | 2016–2017 | 1 | 2a | Industry | 80 | SP-8203 | 80 or 160 mg/d | IV | <4.5 h | Matrix metalloprotease pathway |
| NCT00901381 | Granulocyte-colony Stimulating Factor for Stem Cells Therapy for Acute Ischemic Stroke | Compl | 2007–2009 | 2 | 2 | Research Institute | 20 | Filgrastim | 10 µg/kg | IH | <48 h | Multiple mechanisms(activation of endogenous bone marrow cells and neuroprotection) |
| NCT03394950 | Butyphthalide in Combination With Recombinant Tissue Plasminogen Activator for Acute Ischemic Stroke | Compl | 2018–2021 | 3 | 4 | Hospital | 120 | Butyphthalide | 25 mg | IV | <4.5 h | Multiple mechanisms(PMCA,SERCA) |
| NCT00796887 | Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke Recovery | Compl | 2009–2012 | 3 | 2 | Research Institute | 28 | Extended-Release Niacin | 500 or 1000 mg/d | PO | 3–7days | Multiple mechanisms(TNF-α,TGF-β,cAMP,HDL,LDL) |
| NCT03686163 | Effects of Intranasal Nerve Growth Factor for Acute Ischemic Stroke | Compl | 2016–2020 | 4 | 4 | Hospital | 106 | Nerve Growth Factors | 20 ug/d | IN | <72 h | Multiple mechanisms(TrkA) |
| NCT02828540 | Clinical Trial to Assess the Efficacy and to Evaluate Safety of HT047 in Patients With Acute Ischemic Stroke | Compl | 2016–2018 | 2 | 2 | University | 78 | HT047 | 1500 or 2250 mg/d | PO | <14days | Multiple mechanisms (herbal extracts) |
| NCT01762163 | Efficacy and Safety of Qizhitongluo Capsule in the Recovery Phase of Ischemic Stroke | Compl | 2013–2016 | 3 | 4 | University/College | 622 | Qizhitongluo Capsule Naoxintong Capsule | 12 granules/d 12 granules/d | PO | 15–28 days | Multiple mechanisms (traditional Chinese medicine) |
| NCT01958957 | A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke. | Compl | 2013–2014 | 1 | 4 | Industry | 6300 | Ginkgolides Meglumine Injection | 25 mg/d | IV | 0.5–6 months | Multiple mechanisms (traditional Chinese medicine) |
| NCT01919671 | Tongxinluo Capsule in Ischemic Stroke Patients (TISS) | Compl | 2014–2016 | 2 | 4 | University Hospital | 2007 | Tongxinluo capsule | 12 granules/d | PO | <72 h | Multiple mechanisms (traditional Chinese medicine, mainly vasodilator) |
| NCT04649398 | Cerebral Nimodipine Concentrations Following Oral, Intra-venous, and Intra-arterial Administration | Recruiting | 2020–2023 | 3 | / | University | 30 | Nimodipine | 60 mg | PO/IV | / | Neuroinflammation/BBB |
| NCT04734548 | Phase Ib/IIa Clinical Study of ApTOLL for the Treatment of Acute Ischemic Stroke | Compl | 2020–2022 | 2 | 1, 2 | Ministry | 151 | ApTOLL | 0.025 mg/kg–0.2 mg/kg | IV | <6 h | Neuroinflammation/TLR |
| NCT04453800 | The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke | Compl | 2016–2018 | 2 | 2 | University Hospital | 236 | Sofadil | 500, 750 or 1500 mg | IV | <6 h | NMDA |
| NCT04486430 | Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 h of Onset | Compl | 2017–2019 | 2 | 2 | Hospital | 236 | Neu2000 | 500 mg/750 mg/1500 mg | IV | <6 h | NMDAR |
| NCT04453800 | The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke | Compl | 2016–2018 | 2 | 2 | Hospital | 236 | Neu2000 | 500 mg/750 mg/1501 mg | IV | <6 h | NMDAR |
| NCT00059332 | Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial | Compl | 2005–2013 | 8 | 3 | Research Institute | 1700 | Magnesium sulfate | 4 g | IV | <2 h | N-type Ca2+channel blocker |
| NCT01502761 | Intra-arterial Magnesium Administration for Acute Stroke | Termi | 2012–2016 | 4 | 1,2 | University | 4 | Magnesium sulfate | 0.75 or 1.5 g | IA | N-type Ca2+channel blocker | |
| NCT02912663 | Magnesium And Verapamil After Recanalization in Ischemia of the Cerebrum: a Clinical and Translational Study. | Compl | 2017–2020 | 3 | 1 | University | 10 | Magnesium sulfate Verapamil | 1 g 10 mg | IA | N-type Ca2+channel blocker | |
| NCT05032781 | Intra-Arterial Neuroprotective Agents and Cold Saline in Ischemic Stroke Intervention | Recru | 2021–2022 | 1 | 1 | Industry | 24 | Magnesium sulfate Minocycline | 2 or 4 g 2, 4 or 6 mg/kg | IA | N-type Ca2+channel blocker | |
| NCT02505295 | Selenium and Ischemic Stroke Outcome | Compl | 2015–2018 | 3 | Not applicable | University | 44 | Selenium | 1000 mg | PO | <72 h | Oxidative stress |
| NCT03945526 | Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients | Compl | Mar, 2010-Jun, 2010 | 3 months(0.25) | 1 | University | 24 | Astaxanthine | 2*8 mg | PO | <48 h | Oxidative stress |
| NCT03402204 | Efficacy of High and Low-Dose Simvastatin on Vascular Oxidative Stress and Neurological Outcome in Patients With AIS | Compl | 2014–2015 | 1 | 3 | University | 64 | Simvastatin | 10 mg/40 mg | PO | <24 h | Oxidative stress |
| NCT04931628 | Efficacy and Safety of Salvianolic Acid on AIS | Not Recru | 2022–2023 | 1 | Not applicable | University Hospital | 190 | Salvianolic acid | 100 mg | IV | <72 h | Oxidative stress |
| NCT03539445 | Efficacy and Safety of Butylphthalide for Acute Ischemic Stroke Patients Receiving Intravenous Thrombolysis or Endovascular Treatment | Recruiting | 2018–2022 | 4 | 3 | Hospital | 1200 | Butylphthalide | 0.2 g | IV | / | Oxidative stress |
| NCT02222714 | Safety Evaluation of 3K3A-APC in Ischemic Stroke | Compl | 2014–2017 | 3 | 2 | Industry | 110 | 3K3A-APC | 120, 240, 360 or 540 ug/kg | IV | <4.5 h | PAR1 |
| NCT04950920 | Phase III Clinical Trial of Y-2 Sublingual Tablets in the Treatment of Acute Ischemic Stroke | Compl | 2020–2022 | 2 | / | University Hospital | 900 | Y-2 sublingual tablets | Edaravone 30 mg and d-borneol 6 mg | PO | <48 h | ROS/Neuroinflammation |
| NCT01949948 | Study of Tenecteplase Versus Alteplase for Thrombolysis (Clot Dissolving) in Acute Ischemic Stroke | Compl | 2012–2016 | 4 | 3 | Hospital | 1050 | Tenecteplase | 0.4 mg/kg | IV | <4.5 h | tPA |
| NCT01675115 | Efficacy of BNG-1 to Treat Acute Ischemic Stroke | Compl | 2012–2014 | 2 | 3 | Hospital | 129 | BNG-1 | 9 g/d | PO | <10 days | Unknown |
| NCT01436487 | Study to Examine the Effects of MultiStem in Ischemic Stroke | Compl | 2011–2015 | 4 | 2 | Industry | 134 | MultiStem | 400 or 1200 million | IV | 24–48 h | Unknown(Immunotherapy) |
| NCT02963376 | A Phase Ib/II in Patients With Acute Ischemic Stroke | Compl | 2017–2018 | 1 | 1 | University | 24 | DDFPe | 0.05, 0.10 or 0.17 ml/kg | IV | <12 h | Unknown(lactate) |
| NCT00756249 | Safety Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke | Compl | 2007–2008 | 1 | 1 | Industry | 16 | Lu AA24493 | 0.005, 0.05, 0.5, 5 or 50 mcg/kg | IV | 12–48 h | Unknown(SHH /Patched/Smoothened,Mash1,frataxin) |
| NCT00870844 | Safety and Pharmacokinetic Study of Carbamylated Erythropoietin (CEPO) to Treat Patients With Acute Ischemic Stroke | Compl | 2009–2011 | 2 | 1 | Industry | 24 | Lu AA24493 | 0.5, 5 or 50 mcg/kg | IV | <48 h | Unknown(SHH /Patched/Smoothened,Mash1,frataxin) |
| NCT01678534 | Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial (AMASCIS-01) | Compl | 2014–2017 | 3 | 2 | Hospital | 19 | Allogenic mesenchymal stem cells from adipose tissue | 1 million units/kg | IV | 12 h | Cell therapy |
| NCT01501773 | Intravenous Autologous Bone Marrow-derived Stem Cells Therapy for Patients With Acute Ischemic Stroke | Compl | 2008–2011 | 3 | 2 | Industry | 120 | Autologous bone marrow stem cell | 30–500 million | IV | Sudden onset | Cell therapy |
| NCT01845350 | Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients | Compl | 2013–2016 | 3 | 1 | University | 13 | M2 macrophage introduction | Not applicalble | Intracathecal | 3–12 months | Cell therapy |
| NCT01468064 | Autologous Bone Marrow Stromal Cell and Endothelial Progenitor Cell Transplantation in Ischemic Stroke (AMETIS) | Compl | 2011–2015 | 4 | 1/2 | University | 20 |
Genetic: Autologous BMSCs transplantation Genetic: Autologous EPCs transplantation Genetic: IV infusion of placebo |
2.5 million cells per kg | IV | Within 7 days | Cell therapy |