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

This study has been terminated.
(The study was terminated mutually by the sponsor and PI due to extremely low enrollment over the past year.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01826175
First received: April 1, 2013
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Coronary Artery Disease
Drug: Ticagrelor
Drug: Clopidogrel
Device: Optical Coherence Tomography
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Comparison of Ticagrelor Versus Clopidogrel on Residual Thrombus Burden During Percutaneous Coronary Intervention: an Optical Coherence Tomography Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    The total thrombus burden measured on OCT images will be assessed. The volume of in-stent thrombus will be quantified by planimetry.


Secondary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.

  • 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). ] [ Designated as safety issue: No ]
    The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.


Other Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    PCI related myocardial infarction is defined by the third Universal defintion of myocardial infarction.


Enrollment: 47
Study Start Date: May 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Device: Optical Coherence Tomography
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.
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.
Device: Optical Coherence Tomography

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826175

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
AstraZeneca
Investigators
Principal Investigator: Ik-Kyung Jang, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Ik-Kyung Jang, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01826175     History of Changes
Other Study ID Numbers: 2013P000225
Study First Received: April 1, 2013
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Optical Coherence Tomography
ticagrelor
clopidogrel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Ticagrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014