Coronary Artery DiseasePhase 4NCT01848899

Effects Contrast on Platelet Activity, Thrombosis and Fibrinolysis in Patients Undergoing Coronary Angiography

A Phase 4 study testing Iodixanol, Ioxaglate and Bivalirudin in people with Coronary Artery Disease, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Iodixanol, Ioxaglate and Bivalirudin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: Feb 2013to Nov 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must be more than 18 years of age
referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel).

Who cannot join

on warfarin
on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time >150 at time of procedure -on cilostazol
on persantine
on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure
on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction registry
undergoing coronary angiography via radial access

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undergoing planned diagnostic coronary angiography only
unable to tolerate dual anti-platelet therapy
with known allergy to CM
received CM within 24 hours of coronary angiography
on dialysis
do not consent or are unable to give consent
are participating in another competing study.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Official title: The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial

Conditions: Coronary Artery Disease
Being tested: Iodixanol, Ioxaglate, Bivalirudin
Keywords: Coronary angiography, Percutaneous coronary intervention, Contrast media, Platelet activity, Thrombin generation, Fibrinolysis
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IodixanolDrug
Also called Visipaque
contrast media used during coronary angiography
IoxaglateDrug
Also called Hexabrix
contrast media used during coronary angiography
BivalirudinDrug
Also called Angiomax, Angiox
A direct thrombin inhibitor

Study groups in NCT01848899
Study group	Role	What they receive
Ioxaglate Arm	Experimental	Not described Receives: Drug: Ioxaglate; Drug: Bivalirudin
Iodixanol arm	Experimental	Not described Receives: Drug: Iodixanol; Drug: Bivalirudin

What is being measured

The primary outcome is the main question the study is designed to answer.

Thrombin Generation Test: Baseline
The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.
Measured: baseline
Thrombin Generation Test: After Coronary Angiography
The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.
Measured: 1 hour

Secondary outcomes (3)

Percent Change in Maximal Platelet Aggregation: Epinephrine
Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine
Measured: Baseline to 1 hour
Percent Change in Maximal Platelet Aggregation: Arachidonic Acid
Percent change in maximal platelet aggregation from pre- to post-contrast in response to 1600 μM arachidonic acid
Measured: 1 hour
Percent Change in Maximal Platelet Aggregation: ADP
Percent change in maximal platelet aggregation from pre- to post-contrast in response to 20 μM of ADP
Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2013Nov 2014

First posted8 May 2013 (estimated)
Study startFeb 2013
Primary completionNov 2013
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01848899
Sponsor's protocol ID: 12-02409
Status last verified: Mar 2016
First submitted: 23 Apr 2013
Last updated: 6 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
ClinicalTrials.gov ID: NCT01848899
Acronym / sponsor ID: 12-02409
Conditions: Coronary Artery Disease
Keywords: Coronary angiography, Percutaneous coronary intervention, Contrast media, Platelet activity, Thrombin generation, Fibrinolysis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: Guerbet
Study start: Feb 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2014 (actual)
First posted: 8 May 2013 (estimated)
Results: Posted 6 Apr 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ioxaglate Arm	Experimental	Drug: Ioxaglate, Drug: Bivalirudin
Iodixanol arm	Experimental	Drug: Iodixanol, Drug: Bivalirudin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients must be more than 18 years of age
referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel).

Key exclusion criteria (13 listed)

on warfarin
on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time >150 at time of procedure -on cilostazol
on persantine
on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure
on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction registry

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IodixanolAlso: Visipaquecontrast media used during coronary angiography	Drug	Iodixanol arm
IoxaglateAlso: Hexabrixcontrast media used during coronary angiography	Drug	Ioxaglate Arm
BivalirudinAlso: Angiomax, AngioxA direct thrombin inhibitor	Drug	Iodixanol arm, Ioxaglate Arm

Primary outcome

Thrombin Generation Test: Baseline
Time frame: baseline
The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.
Thrombin Generation Test: After Coronary Angiography
Time frame: 1 hour
The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.

3 secondary outcomes

Percent Change in Maximal Platelet Aggregation: Epinephrine
Time frame: Baseline to 1 hour
Percent Change in Maximal Platelet Aggregation: Arachidonic Acid
Time frame: 1 hour
Percent Change in Maximal Platelet Aggregation: ADP
Time frame: 1 hour

Results and safety

Results posted to the registry on 6 Apr 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ioxaglate Arm	50	50
Iodixanol Arm	50	50

Primary outcome: Thrombin Generation Test: Baseline

Time frame: baseline. Median (Inter-Quartile Range). Unit: nM*minutes

Measure	Ioxaglate Arm n = 43	Iodixanol Arm n = 37
Value	1810 (1540 to 2089)	1682 (1534 to 2147)

Population analysed: A valid thrombogram was generated post-diagnostic angiography in 43/50 participants in the Ioxaglate arm and 37/50 participants in the Iodixanol arm. Thus, not all 100 participants were able to be included in analysis.

Primary outcome: Thrombin Generation Test: After Coronary Angiography

Time frame: 1 hour. Median (Inter-Quartile Range). Unit: nM*minutes

Measure	Ioxaglate Arm n = 43	Iodixanol Arm n = 37
Value	649 (314 to 1347)	681 (229 to 1237)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ioxaglate Arm	0 of 50 (0%)	2 of 50 (4%)	Not reported
Iodixanol Arm	0 of 50 (0%)	1 of 50 (2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fred Feit, MD principal investigator

NYU Langone Health

Binita Shah, MD, MS principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Iodixanol, Ioxaglate and Bivalirudin in people with Coronary Artery Disease, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thrombin Generation Test: Baseline (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01848899.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.