Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

June 17, 2020 updated by: Khaled Ziada, MD

Periprocedural Cangrelor in Patients With ST-Elevation Myocardial Infarction to Reduce Development of Myocardial Necrosis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Reactivity
Time Frame: 10 minutes
Platelet reactivity testing will be performed 10 minutes after infusion has started.
10 minutes
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.
6 hours
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.
6 hours
IFN-γ
Time Frame: 6 hours
ELISA assay.
6 hours
Macrophage-derived Chemokine
Time Frame: 6 hours
ELISA assay macrophage-derived chemokine
6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khaled Ziada, MD

Investigators

  • Principal Investigator: Khaled Ziada, MD, University of Kentucky

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

January 15, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimate)

February 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0990-F6A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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