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

NCT01848899 | Completed Phase 4 Results

• 1 other identifier: 12-02409
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary angiography; Percutaneous coronary intervention; Contrast media; Platelet activity; Thrombin generation; Fibrinolysis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 hour

Secondary Outcomes (3)

• Percent Change in Maximal Platelet Aggregation: Epinephrine

  Baseline to 1 hour

• Percent Change in Maximal Platelet Aggregation: Arachidonic Acid

  1 hour

• Percent Change in Maximal Platelet Aggregation: ADP

  1 hour

Study Arms (2)

Ioxaglate Arm

EXPERIMENTAL

Drug: Ioxaglate; Drug: Bivalirudin

Iodixanol arm

EXPERIMENTAL

Drug: Iodixanol; Drug: Bivalirudin

Interventions

Iodixanol DRUG

contrast media used during coronary angiography

Also known as: Visipaque

Iodixanol arm

Ioxaglate DRUG

contrast media used during coronary angiography

Also known as: Hexabrix

Ioxaglate Arm

Bivalirudin DRUG

A direct thrombin inhibitor

Also known as: Angiomax, Angiox

Iodixanol arm; Ioxaglate Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Guerbet: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

iodixanol; Ioxaglic Acid; bivalirudin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Binita Shah
• Organization: NYU Langone Medical Center

binita.shah@nyumc.org

212-263-4235

Study Officials

• Fred Feit, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Binita Shah, MD, MS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 8, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: April 6, 2016
• Results First Posted: April 6, 2016

Record last verified: 2016-03

Locations

US (1)