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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Ioxaglate; Drug: Iodixanol; Drug: Bivalirudin

• Registration Number: NCT01848899
• Lead Sponsor: NYU Langone Health

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-04-23
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Results First Submitted: 2016-01-29
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Results First Posted: 2016-04-06
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ioxaglate Arm	Ioxaglate	-
Ioxaglate Arm	Bivalirudin	-
Iodixanol arm	Iodixanol	-
Iodixanol arm	Bivalirudin	-

Primary Outcome Measures

Name	Time	Method
Thrombin Generation Test: Baseline	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States