Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size
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|ClinicalTrials.gov Identifier: NCT03043274|
Recruitment Status : Terminated
First Posted : February 6, 2017
Results First Posted : June 30, 2020
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|STEMI - ST Elevation Myocardial Infarction||Drug: Cangrelor||Phase 4|
Cangrelor is a direct-acting and reversible intravenously administered platelet inhibitor approved as an adjunct to percutaneous intervention (PCI) for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis. As it has a quick onset of action (2 minutes) compared to traditional oral platelet inhibitors, cangrelor is emerging as an important new option for use in patients undergoing percutaneous intervention who have not been treated with oral platelet inhibitors.
Furthermore, multiple studies have demonstrated that patients with ST-elevation myocardial infarction (STEMI) who undergo emergent PCI do not have optimal platelet inhibition even after administration of a loading dose of traditional oral platelet inhibitors. However, the clinical significance of complete platelet inhibition around the time of PCI is not fully understood.
The primary objective is to characterize the utility of immediate platelet inhibition with intravenous cangrelor in patients presenting with an acute STEMI by assessing the extent of infarct size (either enzymatically or by imaging). If the findings are favorable, this may suggest that immediate platelet inhibition is an important part of care in this patient population.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Periprocedural Cangrelor in Patients With ST-Elevation Myocardial Infarction to Reduce Development of Myocardial Necrosis|
|Actual Study Start Date :||January 2017|
|Actual Primary Completion Date :||May 2019|
|Actual Study Completion Date :||May 2019|
Approximately 30 patients in this arm will receive standard STEMI care but will also receive standard dosing of cangrelor at the time of their PCI.
Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer.
Other Name: Kengreal
No Intervention: No cangrelor
Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI.
- Change in Myocardial Infarction Size [ Time Frame: 48 hours and 3 months ]Cardiac MRI is obtained at 48 hours and 3 months to compare differences in infarct size. The outcome is assessed as the difference in infarct size between 48 hours and 3 months in each group.
- Platelet Reactivity [ Time Frame: 10 minutes ]Platelet reactivity testing will be performed 10 minutes after infusion has started.
- Peripheral Blood Count Quantification [ Time Frame: 6 hours ]Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.
- Interferon (IFN)-α2 [ Time Frame: 6 hours ]ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.
- IFN-γ [ Time Frame: 6 hours ]ELISA assay.
- Macrophage-derived Chemokine [ Time Frame: 6 hours ]ELISA assay macrophage-derived chemokine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03043274
|United States, Kentucky|
|University of Kentucky|
|Lexington, Kentucky, United States, 40536|
|Principal Investigator:||Khaled Ziada, MD||University of Kentucky|