Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

Study Overview
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Brief Summary
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This study evaluates differences in the extent of myocardial necrosis noted by cardiac MRI in patients with ST-elevation myocardial infarction randomized to receive cangrelor during their percutaneous coronary intervention and compares them to patients randomized to not receive cangrelor.

Detailed Description
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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.

Official Title
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Periprocedural Cangrelor in Patients With ST-Elevation Myocardial Infarction to Reduce Development of Myocardial Necrosis

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Cangrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an acute STEMI with the University of Kentucky as the institution of presentation with plans for PCI English-speaking Exclusion Criteria: Pregnant patients Prisoners Patients who are unable to provide his/her own consent Patients with a prior history of myocardial infarction Patients who have received thrombolytics Patients on systemic anticoagulation Patients who are hemodynamically unstable with evidence of shock Patients who are mechanically intubated Patients with devices not MRI compatible Patients with chronic kidney disease, glomerular filtration rate less than 30 Patients who are already on dual antiplatelet therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cangrelor<br>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. | Drug: Cangrelor<br>* 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.<br>* Other names: Kengreal;|
| No Intervention: No cangrelor<br>Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Myocardial Infarction Size | 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. | 48 hours and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet Reactivity | Platelet reactivity testing will be performed 10 minutes after infusion has started. | 10 minutes | 
| Peripheral Blood Count Quantification | Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes. | 6 hours | 
| Interferon (IFN)-α2 | ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL. | 6 hours | 
| IFN-γ | ELISA assay. | 6 hours | 
| Macrophage-derived Chemokine | ELISA assay macrophage-derived chemokine | 6 hours |