Coronary Vasomotor Response After Riociguat Exposure

Phase 2

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: Riociguat (BAY63-2521)

• Registration Number: NCT01165931
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Study Start: 2012-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-21
• Last Update Posted: 2013-10-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male and female patients with coronary artery disease

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Riociguat (BAY63-2521)	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Adverse event collection	Until 30 days after study drug treatment