Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Stroke Acute
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with MT, in which two therapies are compared: rt-PA or placebo.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The solutions of alteplase or placebo are limpid, transparent and colorless. Alteplase (Actilyse 10 mg powder and solvent for solution for injection and infusion) and placebo will be provided in kind by Boëhringer Ingelheim. The secondary conditioning of the investigation treatment will be performed by Alcura Health Spain S.A.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study objective is to evaluate whether rt-PA is safe and efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a proximal vessel occlusion and successful brain reperfusion on cerebral angiogram (corresponding to m...
The study objective is to evaluate whether rt-PA is safe and efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a proximal vessel occlusion and successful brain reperfusion on cerebral angiogram (corresponding to mTICI score 2b/3) The study is a multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with MT, in which two therapies are compared: rt-PA or placebo. Allocation at each center will account for 1 stratum: use of alteplase (yes vs. no) before MT. Subjects will be followed up to 90 days post-randomization Patients will be enrolled in the angiosuit by interventionalists or neurologists once a mTICI 2b/3 is confirmed on cerebral angiography. The primary outcome is the proportion of patients with a mRS 0 to 1 at 90 days. A sample size of 100 patients per treatment arm in a 1:1 allocation will have at least 80% statistical power for the primary outcome (mRS with 0-1 score values) assuming a rate of 40% in the control arm and a 21% benefit in the experimental arm (odds ratio (OR) of 2.33) for a 5% two-sided type I error. This sample size will also guarantee the study power for that relative treatment benefit even if the success rate in the control group rises up to ?56%. No study losses are accounted for since all randomised patients will be included in the analysis.
Tracking Information
- NCT #
- NCT03876119
- Collaborators
- Fundació La Marató de TV3
- Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Study Chair: Angel Chamorro, MD, PhD Comprehensive Stroke Center, Hospital Clinic Barcelona. Principal Investigator: Arturo Renú, MD, PhD Comprehensive Stroke Center, Hospital Clinic Barcelona. Principal Investigator: Marián Muchada, MD, PhD Hospital Universitario de Vall d'Hebrón Principal Investigator: Elisa Cuadrado, MD, PhD Hospital del Mar Principal Investigator: Anna Ramos, MD Germans Trias i Pujol Hospital Principal Investigator: Pol Camps, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Principal Investigator: Pere Cardona, MD, PhD Hospital Universitari de Bellvitge Principal Investigator: Mikel Terceño, MD Hospital Josep Trueta Girona
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