Intraarterial Alteplase Versus Placebo After Mechanical Thrombectomy

NCT03876119 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-05-20

No results posted yet for this study

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

Placebo

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03876119 on ClinicalTrials.gov