Effects of Oral Levosimendan on Ambulatory Electrocardiographic Variables "Electro"


Phase 2 Results N/A

Eligibility Criteria

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 ┬Ámol/l or on dialysis.
- Blood haemoglobin <10 g/dl; clinically significant hepatic impairment.