AzTrials
AzTrials

STEMI - ST Elevation Myocardial InfarctionPhase 4NCT03043274

Cangrelor in ST-Elevation Myocardial Infarction to Decrease Infarct Size

A Phase 4 study testing Cangrelor in people with STEMI - ST Elevation Myocardial Infarction, run by Khaled Ziada, MD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Cangrelor
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Jan 2017to May 2019
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kentucky

    Lexington, Kentucky, 40536

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Cangrelor
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CangrelorDrug

    Also called Kengreal

    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.

Study groups in NCT03043274
Study groupRoleWhat they receive
CangrelorExperimentalApproximately 30 patients in this arm will receive standard STEMI care but will also receive standard dosing of cangrelor at the time of their PCI.
Receives: Drug: Cangrelor
No cangrelorNo interventionApproximately 30 patients in this arm will receive standard STEMI but will not receive cangrelor at the time of their PCI.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 48 hours and 3 months

Secondary outcomes (5)

  1. Platelet Reactivity

    Platelet reactivity testing will be performed 10 minutes after infusion has started.

    Measured: 10 minutes

  2. Peripheral Blood Count Quantification

    Flow cytometry on peripheral blood will be performed to quantify peripheral counts of inflammatory cells, stem cells, and monocyte subtypes.

    Measured: 6 hours

  3. Interferon (IFN)-α2

    ELISA assay will be performed on plasma to quantify the amount of the inflammatory cytokine interleukin-6 in pg/mL.

    Measured: 6 hours

  4. IFN-γ

    ELISA assay.

    Measured: 6 hours

  5. Macrophage-derived Chemokine

    ELISA assay macrophage-derived chemokine

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2017 (estimated)
  2. Study startJan 2017
  3. Primary completionMay 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03043274
Sponsor's protocol ID
16-0990-F6A
Status last verified
Jun 2020
First submitted
15 Jan 2017
Last updated
30 Jun 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 26201463

  • 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.

    PubMed 26672598

  • 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.

    PubMed 23500251

  • 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.

    PubMed 19264241

  • 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.

    PubMed 22447888

  • 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.

    PubMed 33258102

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cangrelor in people with STEMI - ST Elevation Myocardial Infarction, run by Khaled Ziada, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Myocardial Infarction Size (time frame: 48 hours and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03043274, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in