NCT03043274

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

January 15, 2017

Results QC Date

April 27, 2020

Last Update Submit

June 17, 2020

Conditions

STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Change in Myocardial Infarction Size

    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 Outcomes (5)

  • Platelet Reactivity

    10 minutes

  • Peripheral Blood Count Quantification

    6 hours

  • Interferon (IFN)-α2

    6 hours

  • IFN-γ

    6 hours

  • Macrophage-derived Chemokine

    6 hours

Study Arms (2)

Cangrelor

EXPERIMENTAL

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

No cangrelor

NO INTERVENTION

Approximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI.

Interventions

CangrelorDRUG

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.

Also known as: Kengreal
Cangrelor

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an acute STEMI with the University of Kentucky as the institution of presentation with plans for PCI
  • English-speaking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (6)

  • Keating GM. Cangrelor: A Review in Percutaneous Coronary Intervention. Drugs. 2015 Aug;75(12):1425-34. doi: 10.1007/s40265-015-0445-3.

    PMID: 26201463BACKGROUND

  • Johnson TW, Mumford AD, Scott LJ, Mundell S, Butler M, Strange JW, Rogers CA, Reeves BC, Baumbach A. A Study of Platelet Inhibition, Using a 'Point of Care' Platelet Function Test, following Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction [PINPOINT-PPCI]. PLoS One. 2015 Dec 16;10(12):e0144984. doi: 10.1371/journal.pone.0144984. eCollection 2015.

    PMID: 26672598BACKGROUND

  • Parodi G, Valenti R, Bellandi B, Migliorini A, Marcucci R, Comito V, Carrabba N, Santini A, Gensini GF, Abbate R, Antoniucci D. Comparison of prasugrel and ticagrelor loading doses in ST-segment elevation myocardial infarction patients: RAPID (Rapid Activity of Platelet Inhibitor Drugs) primary PCI study. J Am Coll Cardiol. 2013 Apr 16;61(15):1601-6. doi: 10.1016/j.jacc.2013.01.024. Epub 2013 Mar 22.

    PMID: 23500251BACKGROUND

  • Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schomig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.

    PMID: 19264241BACKGROUND

  • Stone GW, Maehara A, Witzenbichler B, Godlewski J, Parise H, Dambrink JH, Ochala A, Carlton TW, Cristea E, Wolff SD, Brener SJ, Chowdhary S, El-Omar M, Neunteufl T, Metzger DC, Karwoski T, Dizon JM, Mehran R, Gibson CM; INFUSE-AMI Investigators. Intracoronary abciximab and aspiration thrombectomy in patients with large anterior myocardial infarction: the INFUSE-AMI randomized trial. JAMA. 2012 May 2;307(17):1817-26. doi: 10.1001/jama.2012.421. Epub 2012 Mar 25.

    PMID: 22447888BACKGROUND

  • Abo-Aly M, George B, Shokri E, Chelvarajan L, El-Helw M, Smyth SS, Abdel-Latif A, Ziada K. Cangrelor in addition to standard therapy reduces cardiac damage and inflammatory markers in patients with ST-segment elevation myocardial infarction. J Thromb Thrombolysis. 2021 Oct;52(3):934-940. doi: 10.1007/s11239-020-02345-8. Epub 2020 Nov 30.

    PMID: 33258102DERIVED

Related Links

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

cangrelor

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Limitations and Caveats

The study was terminated because of slow recruitment.

Results Point of Contact

Title
Dr. Khaled M. Ziada
Organization
University of Kentucky
khaled.ziada@uky.edu
8593236036

Study Officials

  • Khaled Ziada, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2017

First Posted

February 6, 2017

Study Start

January 1, 2017

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

June 30, 2020

Results First Posted

June 30, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)