Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size
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|ClinicalTrials.gov Identifier: NCT03043274|
Recruitment Status : Recruiting
First Posted : February 6, 2017
Last Update Posted : March 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|STEMI - ST Elevation Myocardial Infarction||Drug: Cangrelor||Not Applicable|
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)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Periprocedural Cangrelor in Patients With ST-Elevation Myocardial Infarction to Reduce Development of Myocardial Necrosis|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 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 will be obtained at 48 hours and 3 months to compare differences in infarct size.
- Platelet reactivity [ Time Frame: 0, 10 minutes, and 2 hours ]Platelet reactivity testing will be performed at prior to cangrelor infusion, 10 minutes after infusion has started, and at the end of the PCI.
- Peripheral blood count quantification [ Time Frame: 6 and 12 hours ]Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.
- Interleukin-1β [ Time Frame: 6 and 12 hours ]ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-1β in pg/mL.
- Interleukin-6 [ Time Frame: 6 and 12 hours ]ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.
- Interleukin-10 [ Time Frame: 6 and 12 hours ]ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-10 in pg/mL.
- Tumor Necrosis factor-α [ Time Frame: 6 and 12 hours ]ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine Tumor Necrosis Factor-α in pg/mL.
- In-hospital mortality [ Time Frame: 30 day ]Review of inpatient medical stay to assess whether patients survived to discharge and if not, explore the reasons for mortality
- 30-Day mortality [ Time Frame: 30 day ]Assess on subsequent patient encounters for outpatient follow-up.
- Major bleeding [ Time Frame: 30 day ]Review in patient bleeding complications as assessed by the Bleeding Academic Research Consortium definition. Will also review rates of access site complications including retroperitoneal bleeding and pseudoaneurysms.
- Composite outcome: Incidence of a composite of in-hospital mortality, 30-day mortality, major bleeding, and access complications will be reported. [ Time Frame: 30 day ]Incidence of a composite of in-hospital mortality, 30-day mortality, major bleeding, and access complications will be reported.
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
|Contact: Khaled Ziada, MDfirstname.lastname@example.org|
|United States, Kentucky|
|University of Kentucky||Recruiting|
|Lexington, Kentucky, United States, 40536|
|Contact: Khaled Ziada, MD email@example.com|
|Sub-Investigator: Ahmed Abdel-Latif, MD|