Coronary Artery Disease
Conditions
Brief summary
This study is intended to investigate the pharmacodynamic drug-drug interaction as well as the safety and tolerability of isosorbite mononitrate and vericiguat in patients with stable coronary artery disease.
Interventions
2.5 mg/tablet; 5 mg/tablet or 10 mg/tablet
DRUGPlacebo
Matching placebo
30 mg/tablet or 60 mg/tablet
Sponsors
Merck Sharp & Dohme LLC
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | Up to 8 weeks | Regular measurements of blood pressure after a vericiguat administration on the first and on the last days of each dose step of vericiguat, and on the first days of ISMN up-titration. |
| Heart rate | Up to 8 weeks | Regular measurements heart rate after a vericiguat administration on the first and on the last days of each dose step of vericiguat, and on the first days of ISMN up-titration. |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to 9 weeks |
Countries
Germany
Outcome results
None listed