Stroke, Transient Ischemic Attack
Conditions
Keywords
An ischaemic cerebrovascular event (stroke or TIA)
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.
Detailed description
This is a prospective, multicentre, phase II, randomized, double-blind, placebo-controlled 2-arm parallel group study with 5 escalating dose-levels of oral levosimendan, each given for 13-18 days. The study population will be randomly allocated either to the levosimendan group or to the placebo group. The double-blind phase with either placebo or levosimendan is preceded by a 13-day long single-blind treatment with placebo (placebo run-in). The study consists of 9 visits (screening visit, 7 visits during the treatment period and an end-of-study visit). Each subject will be on study treatment (including placebo run-in) for 78-108 days and the duration of the study for each subject, including the screening and the end of study visit, is approximately 17 weeks.
Interventions
DRUGLevosimendan
from 0.125 mg to 2 mg in escalating doses
DRUGPlacebo
Placebo capsules are identical in appearance to active capsules
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients 50 to 80 years of age with ischaemic stroke or TIA within 1 to 9 months before the screening visit.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-h Holter reporting | every 2 weeks |
Countries
Finland, Germany, Hungary, Sweden
Outcome results
None listed