NCT00698763

Brief Summary

The primary objective is to explore the safety of low doses of oral levosimendan in patients with recent history of an ischaemic cerebrovascular event (stroke or TIA). The main focus will be on the evaluation of proarrhythmic potential of the different dose regimens.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_2

Geographic Reach
4 countries

7 active sites

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

First Submitted

Initial submission to the registry

June 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

8 months

First QC Date

June 12, 2008

Last Update Submit

November 23, 2009

Conditions

Transient Ischemic AttackStroke

Keywords

An ischaemic cerebrovascular event (stroke or TIA)

Outcome Measures

Primary Outcomes (1)

  • 24-h Holter reporting

    every 2 weeks

Study Arms (2)

A

EXPERIMENTAL

Levosimendan

Drug: Levosimendan

B

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

LevosimendanDRUG

from 0.125 mg to 2 mg in escalating doses

A
PlaceboDRUG

Placebo capsules are identical in appearance to active capsules

B

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit.

You may not qualify if:

  • Stroke or TIA due to cardiac embolism, vasculitis or arterial dissection
  • Severe hemiparesis or dysphasia, haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy, any acute coronary event or angioplasty or any other major surgery within 1 month, any major surgery during the planned study period
  • History of life-threatening ventricular arrhythmia within 3 months.
  • History of Torsades de Pointes (TdP) or family history of long QT-syndrome
  • Heart rate (HR) \< 50 or \> 100 bpm.
  • Systolic blood pressure (SBP) \< 100 mmHg or \> 180 mmHg, or diastolic blood pressure (DBP) \> 100 mmHg.
  • Ventricular tachycardia.
  • Episode of atrial fibrillation or atrial flutter lasting \> 60 seconds.
  • Second or third degree atrioventricular (AV) block.
  • Potassium (K) \< 3.7 mmol/l or \> 5.5 mmol/l.
  • Creatinine \> 170 µmol/l or on dialysis.
  • Blood haemoglobin \<10 g/dl; clinically significant hepatic impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Helsinki University Hospital (HUCH)

Helsinki, Finland

Location

Turku University Hospital (TYKS)

Turku, 20521, Finland

Location

Heidelberg University Clinic

Heidelberg, Germany

Location

Debrecen University

Debrecen, Hungary

Location

Sahlgrenska University Hospital, Dept of Neurology

Gothenburg, 413 45, Sweden

Location

University Hospital, Neurologmottagningen

Linköping, 581 85, Sweden

Location

Umeå University Hospital, Strokecenter NVS

Umeå, 901 85, Sweden

Location

Related Publications (1)

  • Kivikko M, Kuoppamaki M, Soinne L, Sundberg S, Pohjanjousi P, Ellmen J, Roine RO. Oral Levosimendan Increases Cerebral Blood Flow Velocities in Patients with a History of Stroke or Transient Ischemic Attack: A Pilot Safety Study. Curr Ther Res Clin Exp. 2015 Jan 29;77:46-51. doi: 10.1016/j.curtheres.2015.01.001. eCollection 2015 Dec.

    PMID: 26082815DERIVED

MeSH Terms

Conditions

Ischemic Attack, TransientStroke

Interventions

Simendan

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Irja Korpela

    Orion Corporation, Orion Pharma

    STUDY DIRECTOR

  • Risto O. Roine, M.D., Ph.D.

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 17, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2009

Study Completion

September 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

HU(1)DE(1)SE(3)FI(2)