This study is intended to investigate the effect of nitroglycerin on vericiguat in patients with stable coronary artery disease (CAD). Nitroglycerin is the standard therapy to treat acute crisis of angina. Thus there is a high likelihood of co-administration of both drugs in the target indication of vericiguat, worsening heart failure (HF). Therefore, it is important to investigate the safety and tolerability of vericiguat and nitroglycerin, which may be used as unprescribed on-demand treatment by patients with acute episodes of angina pectoris.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets
Placebo for 14 +/-3 days given as 1 or 2 tablets \[o.d.\].
0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat \[trough\] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat \[peak\] or placebo) on day 13, day 27 and day 41
Unnamed facility
Heidelberg, Baden-Wurttemberg, Germany
Unnamed facility
Bonn, North Rhine-Westphalia, Germany
Unnamed facility
Wuppertal, North Rhine-Westphalia, Germany
Unnamed facility
Erfurt, Thuringia, Germany
Number of participants with adverse events as measure of safety and tolerability
Time frame: approximately 1 year
Blood pressure
Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.
Time frame: approximately 1 year
Heart rate
Regular measurement of heart rate (bpm) in supine, sitting and standing position.
Time frame: approximately 1 year
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Unnamed facility
Berlin, Germany
Unnamed facility
Hamburg, Germany