A Phase 4 interventional study of Ticagrelor and Clopidogrel in Acute Coronary Syndrome and Coronary Artery Disease, sponsored by Massachusetts General Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2016-12-20.
Sponsored by Massachusetts General Hospital · Phase 4 and Interventional
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.
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
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Patient Characteristics:
Males and non-pregnant females > 18 and \< 79 years of age presenting with acute coronary syndrome defined as having two of the following criteria:
Lesion Characteristics on Diagnostic Coronary Angiography
Exclusion Criteria:
General Exclusion Criteria
Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by OCT.
Subjects receive 180 mg of ticagrelor immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.
Drug: Ticagrelor · Device: Optical Coherence Tomography
Subjects receive 600 mg of clopidogrel immediately prior to coronary artery stenting and have optical coherence tomography imaging after the stenting procedure.
Drug: Clopidogrel · Device: Optical Coherence Tomography
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.
Also known as: Brilinta, Brilique, Possia
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.
Also known as: Plavix
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.
Also known as: OCT
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.
Time frame: Thrombus burden will be measured at the end of the coronary artery stenting procedure.
PRI (platelet reactivity index) as measured by the PLT-VASP assay.
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
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).
P2Y12 Reaction Units as measured by the VerifyNow P2Y12 assay.
The extent of platelet inhibition will be measured by PLT-VASP and VerifyNow P2Y12 assays.
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).
PCI- related myocardial infarction (MI)
PCI related myocardial infarction is defined by the third Universal defintion of myocardial infarction.
Time frame: PCI-related MI will be assessed within 24 hours after the end of the coronary artery stenting procedure.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital