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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
Sponsor:
Information provided by (Responsible Party):
George Bennet, 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 Not Applicable

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)
Estimated Enrollment : 60 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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 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 will be obtained at 48 hours and 3 months to compare differences in infarct size.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 30-Day mortality [ Time Frame: 30 day ]
    Assess on subsequent patient encounters for outpatient follow-up.

  9. 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.

  10. 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.



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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


Contacts
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Contact: Khaled Ziada, MD kziad2@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Khaled Ziada, MD       kziad2@uky.edu   
Sub-Investigator: Ahmed Abdel-Latif, MD         
Sponsors and Collaborators
George Bennet, MD

Additional Information:
Publications:

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Responsible Party: George Bennet, MD, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT03043274     History of Changes
Other Study ID Numbers: 16-0990-F6A
First Posted: February 6, 2017    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
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