Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During PCI: an OCT Study

December 19, 2016 updated by: Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital

Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study

Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Subjects with acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Subjects that are to be treated clinically with coronary artery stenting will be randomized to receive a loading dose of clopidogrel versus ticagrelor after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the presence of blood clots inside the new stent will be measured and compared between the groups

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patient Characteristics:

  1. Males and non-pregnant females > 18 and < 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:

    1. Signs and symptoms consistent with accelerated angina or prolonged angina (lasting greater than 20 minutes) either at rest or with minimal exertion
    2. ECG changes indicative of new ischemia
    3. Levels of cardiac biomarkers (troponin-T) above the upper limit of the normal range.
  2. Patients scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)

Lesion Characteristics on Diagnostic Coronary Angiography

  1. De novo lesions in native coronary arteries found by diagnostic coronary angiography
  2. Angiographic stenosis <100%
  3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation

Exclusion Criteria:

General Exclusion Criteria

  1. Subjects who are unable or unwilling to sign the informed consent form
  2. Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
  3. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
  4. Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%
  5. Subjects with an ST elevation myocardial infarction
  6. Subjects with hemodynamic or electrical instability (including shock)
  7. Subjects diagnosed with severe, non-catheter-related coronary artery spasm
  8. Subjects who are or may be pregnant
  9. Subjects with known allergies to contrast media
  10. Subjects with renal failure as defined by eGFR < 60.
  11. History of TIA or stroke < 6 months
  12. History of hemorrhagic stroke
  13. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.

Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by OCT.

  1. Lesion located in the left main coronary artery
  2. Lesions that are heavily calcified
  3. Lesions where OCT cannot be performed due to technical difficulties
  4. Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
  5. Lesion in saphenous vein or arterial conduit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ticagrelor
Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.
Drug: Ticagrelor
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Other Names:
  • Brilinta
  • Brilique
  • Possia
Device: Optical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Other Names:
  • OCT
Active Comparator: Clopidogrel
Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.
Device: Optical Coherence Tomography
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Other Names:
  • OCT
Drug: Clopidogrel
Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
Other Names:
  • Plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.
Time Frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure.
The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.
Thrombus burden will be measured at the end of the coronary artery stenting procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRI (platelet reactivity index) as measured by the PLT-VASP assay.
Time Frame: PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
PRI will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
Time Frame: P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
P2Y12 will be measured at the time of OCT image acquistion (which will occur at the end of the coronary artery stenting procedure).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
PCI- related myocardial infarction (MI)
Time Frame: PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure.
PCI related myocardial infarction is defined by the third Universal defintion of myocardial infarction.
PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 5, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013P000225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Ticagrelor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe