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Completed

NCT Number: NCT02617550

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heidelberg, Baden-Wurttemberg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vericiguat (BAY1021189)

Drug

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

Drug

Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].

Nitroglycerin

Drug

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

Primary outcomes

  1. Number of participants with adverse events as measure of safety and tolerability

    Time frame: approximately 1 year

Secondary outcomes

  1. Blood pressure

    Time frame: approximately 1 year

    Regular measurement of blood pressure (mmHg) in supine, sitting and standing position.

  2. Heart rate

    Time frame: approximately 1 year

    Regular measurement of heart rate (bpm) in supine, sitting and standing position.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Evaluation of the Effect of 0.4 mg Nitroglycerin Spray After Pretreatment With Multiple Once Daily Oral Doses of 2.5 mg, 5 mg and 10 mg Vericiguat (BAY 1021189) Each Given Over 14 ± 3 Days on Safety, Tolerability and Blood Pressure in a Multi-center, Randomized, Placebo-controlled, Double-blind Group Comparison Study in Stable Coronary Artery Disease (CAD) Patients Aged 30 to 80 Years

Acronym: VENICE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 1, 2015
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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