- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165931
Coronary Vasomotor Response After Riociguat Exposure (CORONARIES)
October 21, 2013 updated by: Bayer
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The ratio of the coronary blood flow after Riociguat to the corresponding flow observed after adenosine, compared to that after nitroglycerin administration
Time Frame: Within 5 min after completion of the intracoronary Riociguat infusion
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Within 5 min after completion of the intracoronary Riociguat infusion
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event collection
Time Frame: Until 30 days after study drug treatment
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Until 30 days after study drug treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
January 1, 2013
Study Registration Dates
First Submitted
July 15, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (Estimate)
July 20, 2010
Study Record Updates
Last Update Posted (Estimate)
October 23, 2013
Last Update Submitted That Met QC Criteria
October 21, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14550
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
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San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
Clinical Trials on Riociguat (BAY63-2521)
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BayerCompletedPulmonary Disease, Chronic Obstructive | Hypertension, PulmonaryGermany
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BayerCompletedHypertension, PulmonaryBelgium, France, China, Turkey, Portugal, Taiwan, Japan, Singapore, United States, Argentina, Switzerland, Mexico, Austria, Thailand, Canada, Denmark, Germany, Russian Federation, Australia, Italy, Korea, Republic of, Sweden, Poland, United... and more
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BayerCompletedHypertension, PulmonaryTurkey, Austria, Czechia, Russian Federation, Slovakia, Switzerland, Italy, Germany, United Kingdom, France, Belgium, Canada, Colombia, Greece, Luxembourg, Netherlands, Spain, Taiwan, Denmark, Sweden, Argentina, Portugal, Saudi Arabia, Austral... and more
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BayerTerminatedHypertension, Pulmonary | Ventricular Dysfunction, LeftAustria, Germany, Czech Republic
-
BayerRecruitingHypertension, PulmonaryFrance, Italy, Korea, Republic of, Poland, Thailand
-
BayerCompletedPulmonary HypertensionBelgium, France, Spain, Turkey, Portugal, Taiwan, Japan, United States, Switzerland, Korea, Republic of, Austria, Canada, China, Denmark, Germany, Russian Federation, Mexico, Argentina, Netherlands, Italy, Poland, United Kingdom, Au... and more
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BayerCompletedScleroderma, SystemicNetherlands, Belgium, United States, Australia, Hungary, United Kingdom, Canada, Germany, Switzerland, France, Italy, Japan, New Zealand, Turkey, Czechia
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BayerCompletedHypertension, PulmonaryGermany