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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
Sponsor:
Information provided by (Responsible Party):
Khaled Ziada, MD, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
STEMI - ST Elevation Myocardial Infarction Drug: Cangrelor Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Cangrelor

Arm Intervention/treatment
Experimental: 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.
Drug: 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.
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Platelet Reactivity [ Time Frame: 10 minutes ]
    Platelet reactivity testing will be performed 10 minutes after infusion has started.

  2. 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.

  3. 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.

  4. IFN-γ [ Time Frame: 6 hours ]
    ELISA assay.

  5. Macrophage-derived Chemokine [ Time Frame: 6 hours ]
    ELISA assay macrophage-derived chemokine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Khaled Ziada, MD
Investigators
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Principal Investigator: Khaled Ziada, MD University of Kentucky
  Study Documents (Full-Text)

Documents provided by Khaled Ziada, MD, University of Kentucky:
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Khaled Ziada, MD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03043274    
Other Study ID Numbers: 16-0990-F6A
First Posted: February 6, 2017    Key Record Dates
Results First Posted: June 30, 2020
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Heart Diseases
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Cangrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs