NCT01061190

Brief Summary

The objective of this trial is to assess the safety and efficacy of neuro- and cardioprotective effects of propranolol in acute ischemic stroke. Furthermore, exploratory analyses of cardiologic-electrophysiologic and immunologic parameters will be performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 stroke

Timeline
Completed

Started Jan 2010

Typical duration for phase_2 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

1.7 years

First QC Date

February 1, 2010

Last Update Submit

October 12, 2015

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • composite incidence of cardiovascular and/or neurological complications including vascular death

    90 days

Secondary Outcomes (3)

  • mRS and lethality

    90 days

  • number of SAEs and treatment withdrawals

    90 days

  • immunological & cardiological parameters

    90 days

Study Arms (2)

Propranolol

ACTIVE COMPARATOR
Drug: Propranolol

Placebo

PLACEBO COMPARATOR
Drug: Propranolol

Interventions

PropranololDRUG

oral application of 160 mg Propranolol for 30 days

PlaceboPropranolol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptom onset within 18 hours
  • Acute ischemic MCA-territory stroke
  • Patients with suspected stroke in MCA-territory and a) NIHSS \> 3 or b) imaging evidence of MCA-infarction

You may not qualify if:

  • Patients already receiving beta-blockers
  • Anti-arrhythmic, antiinfectious, antiinflammatory or immunosuppressive therapy
  • Patients with a major heart disease, hypotension, bradycardia or any contraindication to the use of Propranolol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, University Berlin, Center for Stroke Research Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Stroke

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Wilhelm Haverkamp, Prof. Dr. med.

    Charité, University Berlin, Center for Stroke Research Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 1, 2010

First Posted

February 3, 2010

Study Start

January 1, 2010

Primary Completion

October 1, 2011

Study Completion

April 1, 2013

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations

DE(1)