Coronary Vasomotor Response After Riociguat Exposure
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Riociguat (BAY63-2521) (Drug)
Phase: Phase 2
Status: Withdrawn
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The aim of the study is to assess the effects of intracoronary Riociguat on coronary blood
flow in subjects with coronary artery disease and to compare this effect with the
intracoronary nitroglycerin, a coronary vasodilator widly used to treat patients with
coronary artery disease.
Clinical Details
Official title: A Study to Compare the Acute Coronary Vasodilating Effects of the sGC Stimulator Riociguat (BAY 63-2521) With the Nitric Oxide Donor Nitroglycerin in Patients With Coronary Artery Disease
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The ratio of the coronary blood flow after Riociguat to the corresponding flow observed after adenosine, compared to that after nitroglycerin administration
Secondary outcome: Adverse event collection
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male and female patients with coronary artery disease
Exclusion Criteria:
- Patents with coronary artery disease with >/= 70% luminal stenosis by coronary
angiography in one of the 3 major epicardial coronary arteries (left anterior
descending artery [LAD], left circumflex coronary artery [LCX] or right coronary
artery [RCA]) undergoing cardiac catheterization
Locations and Contacts
Boston, Massachusetts 02114, United States
Additional Information
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Starting date: May 2012
Last updated: October 21, 2013
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