NCT01165931

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2012

Shorter than P25 for phase_2 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 23, 2013

Status Verified

October 1, 2013

Enrollment Period

8 months

First QC Date

July 15, 2010

Last Update Submit

October 21, 2013

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse event collection

    Until 30 days after study drug treatment

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Riociguat (BAY63-2521)

Interventions

Riociguat (BAY63-2521)DRUG

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).

Arm 1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with coronary artery disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

riociguat

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2010

First Posted

July 20, 2010

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

October 23, 2013

Record last verified: 2013-10

Locations

US(1)