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 - Full Text View

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:

Drug Information available for: Ticagrelor

U.S. FDA Resources

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:

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)
Patients likely to be scheduled to undergo coronary angiography with possible percutaneous coronary intervention (PCI)

Lesion Characteristics on Diagnostic Coronary Angiography:

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

Exclusion Criteria:

Patient Specific Exclusion Criteria:

Subjects who are unable or unwilling to sign the informed consent form.
Subjects being treated with anti-platelet medications other than aspirin prior to diagnostic catheterization including glycoprotein IIb/IIIa inhibitors.
Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study
Subjects with NYHA class III or IV heart failure or known left ventricular ejection fraction < 30%.
Subjects with an ST elevation myocardial infarction.
Subjects with hemodynamic or electrical instability (including shock).
Subjects diagnosed with severe, non-catheter-related coronary artery spasm.
Subjects who are or may be pregnant.
Subjects with known allergies to contrast media.
Subjects with eGFR < 60 ml/min/1.73m2.
Subjects currently taking oral anticoagulants with an absolute contraindication to discontinuation of anticoagulation.
History of TIA or stroke < 6 months.
History of hemorrhagic stroke.
Hepatic insufficiency defined as liver cirrhosis, AST/ALT/Alkaline Phosphatase greater than 3 times the upper limit of normal or hyperbilirubinemia.
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.

Lesions located in the left main coronary artery
Lesions that are heavily calcified
Lesions where OCT cannot be performed due to technical difficulties
Other lesions that the investigator deems inappropriate for the procedure such as sites with excessive tortuosity or low flow by TIMI grade.
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:


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

ClinicalTrials.gov processed this record on March 02, 2015