Vericiguat Drug-drug Interaction With Nitroglycerin in Stable Coronary Artery Disease Patients (VENICE)

Bayer

Status and phase: Completed; Phase 1

Conditions: Coronary Artery Disease

Treatments: Drug: Vericiguat (BAY1021189); Drug: Placebo; Drug: Nitroglycerin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02617550

17849

2015-001444-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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
• Body mass index (BMI): above/equal 18.0 and below/equal 36.0 kg / m²
• Female subjects must be of non-childbearing potential

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
• 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 or patients with stroke at more than 3 months prior with significant residual neurologic involvement
• Insulin dependent diabetes mellitus
• Clinically relevant cardiac ischemia
• Clinical significant persistent ischemia
• Atrial fibrillation, pacemaker, defibrillator, atrial ventricular (AV)-block II and III
• Systolic blood pressure below 110 or above 160 mmHg
• Diastolic blood pressure above 100 mmHg
• Heart rate below 50 or above 100 beats / min
• Estimated glomerular filtration rate < 30 mL/min/1.73m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Vericiguat + Nitroglycerin

Experimental group

Description:

Co-administration of vericiguat and nitroglycerin

Treatment:

Drug: Vericiguat (BAY1021189)

Drug: Nitroglycerin

Placebo + Nitroglycerin

Placebo Comparator group

Description:

Aministration of matching placebo and nitroglycerin.

Treatment:

Drug: Placebo

Drug: Nitroglycerin