Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease Patients (VISOR)
Coronary Artery Disease
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
Patients with stable CAD defined by
- coronary artery stenosis in any of the 3 main coronary vessels > 50% documented by coronary angiography within last 36 months
- or history of myocardial infarction
- Age: 30 to 80 years (inclusive) at the first screening examination
- Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
Exclusion Criteria:
- Intervention e.g. revascularization by percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) during the last 3 months
- Progressive angina with symptoms of worsening of angina within the < 3 months prior to the first screening examination
- History of recent (< 6 months prior to the first screening examination) myocardial infarction or unstable angina
- Symptomatic carotid stenosis, or transient ischemic attack or stroke within 3 months prior to the first screening examination or patients with stroke at more than 3 months prior to the first screening examination with significant residual neurologic involvement
- Insulin dependent diabetes mellitus
- Clinically relevant cardiac ischemia at screening
- Clinical significant persistent ischemia, which should be ruled out by clinical judgment of the investigator, based on medical history, available clinical data e.g. past angiograms or preexisting or current exercise testing with any imaging technique (e.g. dobutamine stress echocardiography, adenosine or dobutamine stress cardiac magnetic resonance imaging (CMR), scinthigraphy or exercise ECG)
- Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III
- Systolic blood pressure below 110 or above 160 mmHg at first screening visit
- Diastolic blood pressure above 100 mmHg at first screening visit
- Heart rate below 50 or above 100 beats / min (taken from ECG measurement) at first screening visit
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m*2 at first screening visit
Sites / Locations
- Universitätsherzzentrum Freiburg - Bad Krozingen
- Universitätsklinikum Heidelberg
- Medizinische Einrichtungen der Universität Bonn
- SocraTec R&D GmbH
- Charité - Campus Virchow-Klinikum (CVK)
- Universitätsklinikum Hamburg Eppendorf (UKE)
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Vericiguat + isosorbite mononitrate
Placebo + isosorbite mononitrate
Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each,prior to start of vericiguat administration. Then subjects received 2.5 mg vericiguat for about 14 days, followed by 5 mg vericiguat for about 14 days, followed by 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of vericiguat administration, taken 1 hour prior to vericiguat (in-house days) or together with vericiguat (out-patient days).
Subjects received Isosorbide mononitrate (ISMN) up-titration with 30 mg / 60 mg, about 7 days each, prior to start of placebo administration. Then subjects received placebo matching 2.5 mg vericiguat for about 14 days, followed by placebo matching 5 mg vericiguat for about 14 days, followed by placebo matching 10 mg vericiguat for about 14 days together 60 mg ISMN od on each day of placebo administration, taken 1 hour prior to placebo (in-house days) or together with placebo (out-patient days).