Coronary Vasomotor Response After Riociguat Exposure (CORONARIES)

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. Identifier: NCT01165931
Recruitment Status : Withdrawn
First Posted : July 20, 2010
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Riociguat (BAY63-2521) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : May 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. 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 :
  1. Adverse event collection [ Time Frame: Until 30 days after study drug treatment ]

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

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

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 identifier (NCT number): NCT01165931

United States, Massachusetts
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01165931     History of Changes
Other Study ID Numbers: 14550
First Posted: July 20, 2010    Key Record Dates
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
Arterial Occlusive Diseases
Vascular Diseases
Vasodilator Agents