NCT03290053 (CE-5S) is a Phase 3 clinical trial of SonoVue in Ischemic Stroke, sponsored by Umeå University.

Who is sponsoring NCT03290053?

NCT03290053 is sponsored by Umeå University.

What drugs are being tested in NCT03290053?

Interventions in NCT03290053: SonoVue, Sodium chloride, Transcranial Ultrasound, Sham Transcranial Ultrasound.

What condition does NCT03290053 study?

NCT03290053 studies Ischemic Stroke.

Is NCT03290053 still recruiting?

NCT03290053 is currently terminated. Last updated 11 May 2018.

Last reviewed 2018-05-11 · How we verify

NCT03290053: CE-5S

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)

Terminated Phase 3 Last updated 11 May 2018

What this trial tests

Phase 3 trial testing SonoVue in Ischemic Stroke in 1 participant. Terminated before completion.

Timeline

28 November 2017

Primary endpoint
18 April 2018

18 April 2018

Quick facts

Lead sponsor	Umeå University
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1
Start date	28 November 2017
Primary completion	18 April 2018
Estimated completion	18 April 2018
Sites	1 location across Sweden

Drugs / interventions tested

SonoVue
Sodium chloride (Sodium Chloride) — full drug profile →
Transcranial Ultrasound
Sham Transcranial Ultrasound

Conditions studied

Ischemic Stroke — all drugs for Ischemic Stroke →

Sponsor

Umeå University

Who can join

18 and older, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with acute ischemic stroke in anterior circulation within 4,5 hours of symptom onset, has a bone window and Trombolysis In Brain Ischemia (TIBI) \<=4 in a relevant artery eligible. Both patients receiving thrombolysis and those who do not due to contraindications such as anticoagulation or recent surgery are enrolled, but into different study arms (CE-5S A for thrombolysis and B for non-thrombolysis); the decision to treat with thrombolysis or not is done according to clinical routine. All included patients are randomized to receive transcranial ultrasound and SonoVue-infusion or sham-ultrasound and placebo; i.e. in CE-5S A, contrast enhanced sonothrombolysis is compared to thrombolysis and in CE-5S B, contrast enhanced sonolysis is compared with conservative management. Main outcome is improvement in National Institute of Health Stroke Scale (NIHSS) at 24 hours compared to baseline. Main safety outcome is symptomatic intracerebral haemorrhage.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of SonoVue

Trials testing the same drug.

NCT07365709 — Liver Cirrhosis Complicated by Clinically Significant Portal Hypertension · NA · not yet recruiting
NCT06497959 — Study of Placental Vascularization Using Contrast Ultrasound · Phase 3 · recruiting
NCT04920214 — Application Value of CEUS Li-RADS in Hepatic Focal Lesions in Patients With Non-high Risk Factors for HCC · unknown
NCT04146441 — Ultrasound-enhanced Uptake of Chemotherapy in Patients With Inoperable Pancreatic Ductal Adenocarcinoma · Phase 2 · completed
NCT03477019 — Ultrasound-enhanced Delivery of Chemotherapy to Patients With Liver Metastasis From Breast- and Colorectal Cancer · Phase 1, PHASE2 · completed

Other recruiting trials for Ischemic Stroke

Currently open trials in the same condition.

NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting

Other Umeå University trials

Trials by the same sponsor.

NCT07407946 — Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion · NA · recruiting
NCT07346820 — VDJ-recombination of the B-cell Receptor Following Hematopoietic Stem Cell Transplantation · not yet recruiting
NCT07417358 — Single-Stapled Technique for Colorectal Anastomosis · recruiting
NCT07316426 — Preoptimisation in Ventral Hernia Surgery · NA · recruiting
NCT07170722 — Sub-threshold DRG Stimulation vs Sham in Established Responders · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03290053 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Umeå University
Last refreshed: 11 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03290053.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing