stop_circleTerminated/Withdrawn

Coronary artery disease

Bayer Identifier:

14550

ClinicalTrials.gov Identifier:

NCT01165931

EudraCT Number:

Not Available

EU CT Number:

Not Available
Coronary vasomotor response after Riociguat Exposure

Trial 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.

Key Participants Requirements

Sex

Both

Age

18 - 90 Years
  • - Male and female patients with coronary artery disease
  • - 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

Trial summary

Enrollment Goal
0
Trial Dates
May 2012 - January 2013
Phase
Phase 2
Could I Receive a placebo
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Boston, 02114, United States

Primary Outcome

  • The ratio of the coronary blood flow after Riociguat to the corresponding flow observed after adenosine, compared to that after nitroglycerin administration
    date_rangeTime Frame:
    Within 5 min after completion of the intracoronary Riociguat infusion
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Adverse event collection
    date_rangeTime Frame:
    Until 30 days after study drug treatment
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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