Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy
NCT03876119 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2022-05-20
Summary
Multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with mechanical thrombectomy (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.
Conditions
- Stroke, Acute
Interventions
- DRUG
-
Intraarterial alteplase
See arm/group descriptions.
- DRUG
-
See arm/group descriptions.
Sponsors & Collaborators
-
Fundació La Marató de TV3
collaborator OTHER -
Fundacion Clinic per a la Recerca Biomédica
collaborator OTHER -
Hospital Clinic of Barcelona
lead OTHER
Principal Investigators
-
Angel Chamorro, MD, PhD · Comprehensive Stroke Center, Hospital Clinic Barcelona.
-
Arturo Renú, MD, PhD · Comprehensive Stroke Center, Hospital Clinic Barcelona.
-
Marián Muchada, MD, PhD · Hospital Universitario de Vall d'Hebrón
-
Elisa Cuadrado, MD, PhD · Hospital del Mar
-
Anna Ramos, MD · Germans Trias i Pujol Hospital
-
Pol Camps, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
-
Pere Cardona, MD, PhD · Hospital Universitari de Bellvitge
-
Mikel Terceño, MD · University Hospital of Girona Dr. Josep Trueta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-12-05
- Primary Completion
- 2021-05-31
- Completion
- 2021-05-31
Countries
- Spain
Study Locations
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