Effect of Pretreatment With Ticagrelor on Residual Thrombus After PCI in Patients Presenting With ACS in Comparison With Delayed Treatment at the Time of PCI: an OCT Study

This study has been withdrawn prior to enrollment.
(Despite a large number of patients screened, very few met eligibility guidelines.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01916902
First received: August 2, 2013
Last updated: May 23, 2014
Last verified: May 2014
  Purpose

Subjects presenting with probable acute coronary syndromes scheduled for cardiac catheterization will be enrolled in this study. Consented subjects will be randomized to receive ticagrelor started with a loading dose immediately after enrollment versus receiving a loading dose of ticagrelor during cardiac catheterization after diagnostic angiography but prior to stenting. Optical coherence tomography (OCT) will be performed after stenting and the volume of thrombus within the new stent will be measured and compared between the groups.


Condition Intervention Phase
Acute Coronary Syndrome
Coronary Artery Disease
Drug: Ticagrelor- Delayed Administration
Drug: Ticagrelor- Immediate Administration
Procedure: Optical Coherence Tomography
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Effect of Pretreatment With Ticagrelor on Residual Thrombus After Percutaneous Coronary Intervention (PCI) in Patients Presenting With Acute Coronary Syndrome in Comparison With Delayed Treatment at the Time of PCI: 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 bu the PLT-VASP assay. [ Time Frame: PRI iwill be measured at the time of OCT image acquisition. ] [ 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 acquisition. ] [ 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 assesed 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 definition of myocardial infarction.


Enrollment: 0
Study Start Date: February 2014
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ticagrelor- Delayed Administration
Subjects receive 180 mg of ticagrelor during cardiac catheterization after diagnostic angiography and prior to stenting. OCT is performed prior to and after coronary artery stenting.
Drug: Ticagrelor- Delayed Administration
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
Procedure: Optical Coherence Tomography
Active Comparator: Ticagrelor- Immediate Administration
Subjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting.
Drug: Ticagrelor- Immediate Administration
Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
Procedure: 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 > or equal to 18 and < or equal to 79 years of age presenting with suspected acute coronary syndrome (unstable angina or NSTEMI)
  2. Patients likely to be 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:

Patient Specific 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 eGFR < 60 ml/min/1.73m2.
  11. Subjects currently taking oral anticoagulants with an absolute contraindication to discontinuation of anticoagulation.
  12. History of TIA or stroke < 6 months.
  13. History of hemorrhagic stroke.
  14. Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
  15. Cardiac catheterization scheduled within 4 hours of randomization or more then 72 hours after randomization.

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

  1. Lesions 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. Lesions in saphenous vein grafts or arterial conduits.
  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: NCT01916902

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: NCT01916902     History of Changes
Other Study ID Numbers: 2013P001322
Study First Received: August 2, 2013
Last Updated: May 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Optical Coherence Tomography
Ticagrelor

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Thrombosis
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Embolism and Thrombosis
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 09, 2014