Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-05-31

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.

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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.

Conditions

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STEMI - ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cangrelor

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.

Group Type EXPERIMENTAL

Cangrelor

Intervention Type DRUG

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.

No cangrelor

Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cangrelor

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.

Intervention Type DRUG

Other Intervention Names

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Kengreal

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No