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NCT01165931 Clinical Trial

Coronary Vasomotor Response After Riociguat Exposure

Coronary Artery Disease Clinical Trial

— CORONARIES  

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01165931
Other study ID # 14550
Secondary ID
Status Withdrawn
Phase Phase 2
First received July 15, 2010
Last updated October 21, 2013
Start date May 2012
Est. completion date January 2013

Study information
Verified date October 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Riociguat (BAY63-2521)
0.1 mg intracoronary infusion through coronary guide catheter. Single dose. Sequential application after initial vasoactive bolus of Adenosine (non-study drug) and Nitroglycerin (non-study drug).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The ratio of the coronary blood flow after Riociguat to the corresponding flow observed after adenosine, compared to that after nitroglycerin administration Within 5 min after completion of the intracoronary Riociguat infusion No
Secondary Adverse event collection Until 30 days after study drug treatment Yes
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