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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Acute Coronary Syndrome; Coronary Artery Disease	Drug: Ticagrelor- Delayed Administration; Drug: Ticagrelor- Immediate Administration; Procedure: Optical Coherence Tomography	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (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
Study Start Date :	February 2014
Estimated Primary Completion Date :	February 2015

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. PRI (platelet reactivity index) as measured bu the PLT-VASP assay. [ Time Frame: PRI iwill be measured at the time of OCT image acquisition. ]
   The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
2. P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay. [ Time Frame: P2Y12 will be measured at the time of OCT image acquisition. ]
   The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.

Other Outcome Measures:

1. 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. ]
   PCI related myocardial infarction is defined by the third Universal definition of myocardial infarction.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 79 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	August 6, 2013
Last Update Posted:	May 26, 2014
Last Verified:	May 2014

Keywords provided by Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital:

Optical Coherence Tomography; Ticagrelor

Additional relevant MeSH terms:

Syndrome; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome; Disease; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis	Arterial Occlusive Diseases; Vascular Diseases; Ticagrelor; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs