Acute Ischemic Stroke MedDRA version: 22.1 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 22.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0 Level: HLT Classification code 10008192 Term: Cerebrovascular and spinal necrosis and vascular insufficiency System Organ Class: 10047065 - Vascular disorders MedDRA version:
Conditions
Interventions
Trade Name: AGGRASTAT® (50 micrograms/ml) solution for infusion
Product Name: Tirofiban Agrastat ®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: TIROFIBAN HYDROCHLORIDE MONOHYDRATE
C
Sponsors
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI).
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement. • The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion. • ASPECTS (Alberta Stroke Program Early computerized Tomography Score) =6. • Greater than or equal to 18 years of age. • Signed informed consent. 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 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: • Patients under 18 years of age. • Patients with ASPECTS 2. • Severe allergy to contrast medium. • Pregnant. • Patients with intracranial occlusive arteriosclerotic disease or extra or intracranial dissection. • Documented allergy to acetylsalicylic acid or Tirofiban. • Personal history of platelet penia (Platelets 1.7 in case of anti-vitamin K treatment or taking direct oral anticoagulant <48 hours ago) • Medical history of the patient that carries a high risk of bleeding according to the investigator's criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of the use of tirofiban versus aspirin in patients with ischemic stroke secondary to tandem injury, by determining the rate of reocclusion as well as determining the rate of symptomatic bleeding defined as any hemorrhagic transformation associated with a worsening of 4 or more points on the National Institutes of Health Stroke Scale.;Secondary Objective: - Determine the rescue therapy rate in the presence of intra-stent aggregation phenomena during the procedure - Detection of good functional prognosis rates at 90 days in the different subgroups (defined as a score on the modified Rankin scale (mRS) between 0-2). - Improve the pathophysiological knowledge of the complications associated with the endovascular treatment of tandem lesions (re-occlusion) through the identification of related plasma biomarkers. - Assessment of any of the biomarkers identified as a therapeutic target for reocclusion. - Reocclusion or significant restenosis at 30 days.;Primary end point(s): 1. Carotid Reocclusion. Carotid reocclusion will be assessed on ultrasound doppler within first 24-36 hours after mechanical thrombectomy and it is defined by the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, redblue just proximal to the occlusion). In addition, the image detected in mode B will show an anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes. In addition, carotid reocclusion will be evaluated on angio-Computerized Tomography that will demonstrate complete blockage of the artery. 2. Platelet aggregation phenomena. Parietal irregularity in the intra-stent contrast filling. 3. Symptomatic intracranial hemorrhage (sICH). The sICH is defined as a new intracranial hemorrhage in brain computerized tomography within hospi | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Good functional prognosis. Defined as a score on the modified rankin scale (mRS) between 0-2 at 90 days.;Timepoint(s) of evaluation of this end point: Quarterly basis (singe evaluation). | — |
Countries
Spain
Contacts
Public ContactUICEC-HUVR
Unidad de Investigación Clínica y Apoyo a Ensayos Clínicos
Outcome results
None listed