Periprocedural Cangrelor in Patients With ST-Elevation Myocardial Infarction to Reduce Development of Myocardial Necrosis
Overview
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Khaled Ziada, MD
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Change in Myocardial Infarction Size
Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Cangrelor (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Platelet Reactivity(10 minutes)
- Peripheral Blood Count Quantification(6 hours)
- Interferon (IFN)-α2(6 hours)
- IFN-γ(6 hours)
- Macrophage-derived Chemokine(6 hours)
Investigators
Khaled Ziada, MD
Principal Investigator
University of Kentucky