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

NYU Langone Health100 enrolled

Overview

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 thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

100

Conditions

Coronary Artery Disease

Interventions

IodixanolDRUG

contrast media used during coronary angiography

IoxaglateDRUG

contrast media used during coronary angiography

BivalirudinDRUG

A direct thrombin inhibitor

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline

Thrombin Generation Test: After Coronary Angiography

Time frame: 1 hour

Secondary Outcomes

Percent Change in Maximal Platelet Aggregation: Epinephrine

Percent change in maximal platelet aggregation from pre- to post-contrast in response to 10 μM epinephrine

Time frame: 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

Time frame: 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

Time frame: 1 hour

Data from ClinicalTrials.gov

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