Acute Ischemic Stroke MedDRA version: 20.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000013700
Conditions
Interventions
Product Name: NA
Pharmaceutical Form: Tablet
INN or Proposed INN: NA
CAS Number: 123
Current Sponsor code: 123
Other descriptive name: HYDROCHLORIC ACID, CONCENTRATED
Concentration unit: % percent
Con
Sponsors
institute de Recherches Internacionales Servier (promotor internacional)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adult patients (= 18 years old) within 4.5 hours after ischemic stroke symptoms onset (or last time known normal), - Imaging evidence of cerebral artery occlusion in anterior circulation: proximal (internal carotid artery (ICA), middle cerebral artery M1 (MCA-M1) or distal (MCA-M2, MCA-M3) arteries, - Eligible for pharmacological thrombolysis alone or followed by EVT according to current clinical guidelines, - Complete informed consent signed (by the patient or an authorized representative according to local regulation) prior to participation in the trial or within 12 hours if an abbreviated informed consent has been signed prior to the participation in the trial (by the patient or an authorized representative according to local regulation) or orally agreed by the patient and witnessed by a person according to local regulation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
Exclusion criteria
Exclusion criteria: - Any known serious disease (including active malignancy, active infection) likely to interfere with the conduct of the study, according to investigator’s judgment, - Known pregnant or breastfeeding woman, - Patients unlikely to cooperate in the study, - Participation in another interventional study at the same time or within the past 3 months (participation in non-interventional registries or epidemiological studies is allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary exploratory objective is to assess the systemic plasma kinetics of the active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) during the acute stage of ischemic stroke in patients eligible for recombinant tissue Plasminogen Activator (rtPA) thrombolysis alone or rtPA thrombolysis followed by endovascular thrombectomy (EVT).;Secondary Objective: Other exploratory objectives are: - To assess systemic TAFIa levels according to cerebral arteries occlusion site in anterior circulation (proximal or distal artery), - To assess systemic TAFIa levels in ischemic stroke patients treated by rtPA thrombolysis ± EVT, - To assess TAFIa levels according to the stroke clinical severity (National Institute of Health Stroke Score (NIHSS)) at baseline and 24h, - To assess tissue plasminogen activator (tPA) plasma kinetic during acute stage of ischemic stroke in patients eligible for rtPA-thrombolysis alone or followed by EVT, - To assess several haemostasis parameters according to systemic TAFIa levels, - To assess in situ peri-thrombus TAFIa level in EVT eligible patients via blood sampling collected upstream to proximal part of the thrombus through intra-arterial catheter used for EVT, - To assess TAFIa levels according to the characteristics of the clot retrieved during EVT (clot composition, clot weight).;Primary end point(s): Biomarker TAFIa: Systemic TAFIa plasma level assessment in patients receiving rtPA treatment (group A) or rtPA + EVT treatment (group B).;Timepoint(s) of evaluation of this end point: - Groups A and B: intravenous blood samples over 24h after rtPA administration - Group B only: one arterial blood sample through the EVT catheter immediately before first pass | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Biomarker tPA: tPA kinetic measurements in groups A and B - Hemostasis parameters: D-Dimers, Fibrinogen, Fibrin Degradation Products, plasminogen, plasmin-anti-plasmin complexes assessment in groups A and B - Main clinical assessment and collected data Groups A and B: NIHSS score assessment, imaging thrombus characteristics and infarct volume, etiology of the stroke according to TOAST classification, early ischemic change in Middle Cerebral Artery territory and platelet count Group B only if performed in the hospital common practice, collection of thrombolysis in Cerebral Infarction (TICI) score and characteristics of the clot retrieved during EVT. - Safety measurements: all adverse events and other situations relevant to the safety of the participants;Timepoint(s) of evaluation of this end point: - Biomarker tPA: IV blood samples over 24h after rtPA administration - Hemostasis parameters: IV blood samples over 24h after rtPA administration - Main clinical assessment and collected data: NIHSS score assessment at baseline and at 24h, imaging thrombus characteristics and infarct volume at inclusion and 24±4h, etiology of the stroke according to TOAST classification, early ischemic change in Middle Cerebral Artery territory and platelet count at baseline. TICI score at baseline (before thrombolysis), after EVT in case of follow-up imaging and at 24 ± 4 hours. Characteristics of the clot: after EVT - Safety measurements: all over the study | — |
Countries
Spain
Contacts
Public ContactDpto. de Investigacion y Desarrollo
Laboratorios Servier S.L
Outcome results
None listed