NCT01890421 (GadaCAD 1) is a Phase 3 clinical trial of Gadobutrol (Gadovist, Gadavist, BAY86-4875) in Coronary Artery Disease, sponsored by Bayer.

Who is sponsoring NCT01890421?

NCT01890421 is sponsored by Bayer.

What drugs are being tested in NCT01890421?

Interventions in NCT01890421: Gadobutrol (Gadovist, Gadavist, BAY86-4875).

What condition does NCT01890421 study?

NCT01890421 studies Coronary Artery Disease.

Is NCT01890421 still recruiting?

NCT01890421 is currently completed. Last updated 16 May 2018.

Are results published for NCT01890421?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-05-16 · How we verify

NCT01890421: GadaCAD 1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Gadobutrol/Gadavist-enhanced Cardiac Magnetic Resonance Imaging (CMRI) to Detect Coronary Artery Disease (CAD)

Completed Phase 3 Results posted Last updated 16 May 2018

What this trial tests

Phase 3 trial testing Gadobutrol (Gadovist, Gadavist, BAY86-4875) in Coronary Artery Disease in 426 participants. Completed in 31 August 2017.

Timeline

19 July 2013

Primary endpoint
10 April 2015

31 August 2017

Quick facts

Lead sponsor	Bayer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	426
Start date	19 July 2013
Primary completion	10 April 2015
Estimated completion	31 August 2017
Sites	23 locations across France, New Zealand, United Kingdom, Germany, South Korea, Switzerland, United States

Drugs / interventions tested

Gadobutrol (Gadovist, Gadavist, BAY86-4875) — full drug profile →

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Bayer — full company profile →

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Sensitivity Based on Blinded Readers' Assessment Primary · 0 to 30/40 minute (min) post-injection

Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfus

Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	76.6	68.7 – 83.3

Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	65.2	56.8 – 73.1

Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	64.5	56.0 – 72.4

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Sensitivity Based on the Blinded Readers' Assessment Primary · 0 to 30/40 min post-injection

Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for secondary analysis, and was determined based on the presence of a myocardial perf

Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	89.8	82.5 – 94.8

Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	79.6	70.8 – 86.8

Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	78.7	69.8 – 86.0

Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Primary Analysis of Specificity Based on the Blinded Readers' Assessment Primary · 0 to 30/40 min post-injection

Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	85.1	79.9 – 89.4

Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	92.3	88.2 – 95.4

Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	91.9	87.7 – 95.1

Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI (Based on RPS) - Additional Secondary Analysis of Specificity Based on the Blinded Readers' Assessment Primary · 0 to 30/40 min post-injection

Blinded readers evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest)\]. A myocardial region a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfus

Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	82.8	77.8 – 87.2

Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	91.0	87.0 – 94.2

Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	90.7	86.5 – 93.9

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Primary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment Primary · 0 to 30/40 min post-injection

Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=50% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (tr

Gadobutrol-enhanced CMRI-Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	76.6

Gadobutrol-enhanced CMRI-Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	65.2

Gadobutrol-enhanced CMRI-Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	64.5

Unenhanced CMRI-Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	77.3

Unenhanced CMRI-Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	36.2

Unenhanced CMRI-Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	40.4

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on the Blinded Readers' Assessment Primary · 0 to 30/40 min post-injection

Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by blinded readers' assessment. Significant CAD was defined as quantitative coronary angiography (QCA) stenosis of \>=70% for primary analysis, and was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) verified by standard of reference (SoR). Sensitivity= true positive/ (tr

Gadobutrol-enhanced CMRI-Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	89.8

Gadobutrol-enhanced CMRI-Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	79.6

Gadobutrol-enhanced CMRI-Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	78.7

Unenhanced CMRI-Reader 1

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	82.4

Unenhanced CMRI-Reader 2

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	45.4

Unenhanced CMRI-Reader 3

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	48.1

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Sensitivity Based on Investigator's Assessment Secondary · 0 to 30/40 min post-injection

Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=50%). Sensitivity= true positive/ (true positive + false negative).

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	74.3	66.2 – 81.3

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment Secondary · 0 to 30/40 min post-injection

Presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI versus the presence of wall motion abnormalities on unenhanced CMRI images (based on regional perfusion/regional wall motion score of the 6 myocardial regions) was calculated by investigator's assessment. Significant CAD was determined based on the presence of a myocardial perfusion defect on gadobutrol-enhanced CMRI or the presence of wall motion abnormalities on unenhanced CMRI images verified by SoR (significant CAD defined as QCA stenosis of \>=70%). Sensitivity= true positive/ (true positive + false negative). This addi

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	89.8	82.5 – 94.8

Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Secondary Analysis of Specificity Based on Investigator's Assessment Secondary · 0 to 30/40 min post-injection

Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined as maximum steno

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	85.9	80.8 – 90.1

Absence of a Myocardial Perfusion Defect Excluding Significant CAD Per Participant on Gadobutrol-enhanced CMRI - Additional Secondary Analysis of Specificity Based on Investigator's Assessment Secondary · 0 to 30/40 min post-injection

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	85.0	80.1 – 89.0

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment Secondary · 0 to 30/40 min post-injection

Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined

Gadobutrol-enhanced CMRI

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	74.3

Unenhanced CMRI

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	46.4

Presence of a Myocardial Perfusion Defect Indicating Significant CAD Per Participant on Gadobutrol-enhanced CMRI Versus Unenhanced Wall Motion CMRI Images - Additional Secondary Analysis of Sensitivity Comparison Based on Investigator's Assessment Secondary · 0 to 30/40 min post-injection

Investigator's assessment evaluated 6 myocardial regions based on regional perfusion score (RPS), 0=normal; 1=abnormal, reversible perfusion defect (stress); 2=abnormal, mixed perfusion defect (reversible and fixed/permanent components); 3=abnormal, fixed/permanent perfusion defect/scar (stress and rest). A myocardial region was rated to have a perfusion defect in case of a RPS of \>=1 and was rated to have normal perfusion in case of a RPS of 0. The investigator's assessment of participant-based sensitivity and specificity of gadobutrol-enhanced CMRI was analyzed with significant CAD defined

Gadobutrolenhanced:True Positive(Sensitivity)

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	89.8

Unenhanced: True Positive (Sensitivity)

Group	Value	95% CI
Gadobutrol 0.1 mmol/kg Body Weight	57.4

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of gadobutrol injection until 24 ± 6 hours follow-up. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gadobutrol 0.1 mmol/kg Body Weight

Serious: 1/426 (0%)

Deaths: 0/426

Serious adverse events (1 terms)

Reaction	System	Gadobutrol 0.1 mmol/kg Bod…
Chest pain	General disorders	—

Other adverse events (36 terms — click to expand)

Reaction	System	Gadobutrol 0.1 mmol/kg Bod…
Chest discomfort	General disorders	—
Headache	Nervous system disorders	—
Angina pectoris	Cardiac disorders	—
Feeling hot	General disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Dizziness	Nervous system disorders	—
Chest pain	General disorders	—
Blood pressure decreased	Investigations	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Muscle tightness	Musculoskeletal and connective tissue disorders	—
Head discomfort	Nervous system disorders	—
Paraesthesia	Nervous system disorders	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—
Hypertensive crisis	Vascular disorders	—
Bradycardia	Cardiac disorders	—
Extrasystoles	Cardiac disorders	—
Palpitations	Cardiac disorders	—
Abdominal discomfort	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Pain	General disorders	—
Oxygen saturation decreased	Investigations	—
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	—
Limb discomfort	Musculoskeletal and connective tissue disorders	—
Presyncope	Nervous system disorders	—
Sciatica	Nervous system disorders	—
Tremor	Nervous system disorders	—
Anxiety	Psychiatric disorders	—
Panic reaction	Psychiatric disorders	—
Sleep disorder	Psychiatric disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Hyperventilation	Respiratory, thoracic and mediastinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Hypertension	Vascular disorders	—
Microangiopathy	Vascular disorders	—

Most-reported serious reactions: Chest pain.

Data from ClinicalTrials.gov NCT01890421 adverse events section.

Sponsor's own description

Participants being evaluated for suspected or known Coronary artery Disease (CAD) based on signs and/or symptoms, will be invited to participate in the study. The duration for a participant in the study may range from 2 days to 4-6 weeks. One to four visits to the study doctor will be required. This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging (CMRI) images regarding the detection (sensitivity) and exclusion (specificity) of coronary artery disease utilizing a uniform image acquisition software. The CMR images will be tested either against the results from routine clinical Coronary Angiography (CA) or those from Computed Tomography Angiography (CTA), which is used as the standard of reference. The CA/CTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 4/6 weeks after the study. CMRI and CA/CTA images will be collected for an independent image review (blinded read).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01890421 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 16 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01890421.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01890421: GadaCAD 1

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Coronary Artery Disease

Other Bayer trials

Verify against primary sources