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Coronary Vasomotor Response After Riociguat Exposure (CORONARIES)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165931
First Posted: July 20, 2010
Last Update Posted: October 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Drug: Riociguat (BAY63-2521) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse event collection [ Time Frame: Until 30 days after study drug treatment ]

Enrollment: 0
Study Start Date: May 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165931


Locations
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01165931     History of Changes
Other Study ID Numbers: 14550
First Submitted: July 15, 2010
First Posted: July 20, 2010
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by Bayer:
Coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Nitroglycerin
Vasodilator Agents