Study Stopped
Despite a large number of patients screened, very few met eligibility guidelines.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2013
CompletedFirst Posted
Study publicly available on registry
August 6, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedMay 26, 2014
May 1, 2014
1 year
August 2, 2013
May 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total thrombus burden as measured by the volume of in-stent thrombus quantified by planimetry.
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 Outcomes (2)
PRI (platelet reactivity index) as measured bu the PLT-VASP assay.
PRI iwill be measured at the time of OCT image acquisition.
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
P2Y12 will be measured at the time of OCT image acquisition.
Other Outcomes (1)
PCI-related myocardial infarction (MI)
PCI-related MI will be assesed within 24 hours after the end of the coronary artery stenting procedure.
Study Arms (2)
Ticagrelor- Delayed Administration
ACTIVE COMPARATORSubjects 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.
Ticagrelor- Immediate Administration
ACTIVE COMPARATORSubjects receive 180 mg of ticagrelor immediately after study enrollment. OCT is performed prior to and after coronary artery stenting.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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.
- Lesions located in the left main coronary artery
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- AstraZenecacollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ik-Kyung Jang, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 2, 2013
First Posted
August 6, 2013
Study Start
February 1, 2014
Primary Completion
February 1, 2015
Last Updated
May 26, 2014
Record last verified: 2014-05