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Myocardial InfarctionCAMEONCT04076813

Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

An observational study of Myocardial Infarction, run by Chiesi USA, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this registry is to address optimal platelet inhibition during the early management of MI patients prior to coronary angiography or CABG. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
How many people
5,050 participants
Where
11 sitesUnited States
Study dates
16 Oct 2019to 15 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: ≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI.

Phase 1 Inclusion Criteria:

For the first 50 patients at each participating site, consecutive patients are entered in the registry if they are ≥ 18 years of age, underwent coronary angiography for a STEMI or NSTEMI, and received cangrelor at any time during the hospitalization or an oral P2Y12 inhibitor during his/her first 48 hours of the hospitalization for MI.

Phase 2 Inclusion Criteria:

Subsequent patients are eligible to be entered in the registry if they are ≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI and meet at least 1 of the following criteria:

  1. The patient was hospitalized for STEMI and met one of the following inclusion criteria:
  • The patient received cangrelor at any time during his/her hospitalization for MI.
  • The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:
  • The patient received a P2Y12 inhibitor and an opiate/opioid within 24 hours prior to or during primary PCI for STEMI presentation. OR
  • The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG.
  1. The patient was hospitalized for NSTEMI and met one of the following inclusion criteria:
  • The patient received cangrelor during his/her hospitalization for MI.
  • The patient received an oral P2Y12 inhibitor during his/her first 48 hours of hospitalization AND either of the following:
  • The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG. OR
  • Any 2 of the following criteria without prior PCI or CABG: age> 60 years, male sex, diabetes, EF <40% prior heart failure

Exclusion Criteria: If the patient does not meet the inclusion criteria for either Phase.

Phase 3 Eligibility Criteria:

The Phase 3 portion of the CAMEO registry will focus on launching local site quality improvement initiatives with the goal of optimizing cangrelor usage according to FDA-approved established treatment strategy. Enrollment for the registry will be extended for an additional two years to include an additional 2,000 patients in this phase of the registry. The inclusion criteria of these patients will be the same as in Phase 2 (see section 3.3.2). We will also capture which patients are cared for at each site by individual operators. Operator-level data will be de-identified, and each operator will be assigned an operator ID. Sites will be asked to maintain a crosswalk for operator ID, and complete an operator characteristics survey. The operator characteristics survey will ask questions around age, sex, and other relevant operator characteristics, and will be used in the analysis phase in aggregate. Operators will not be directly identified and the analytics center will not have access to the crosswalk, which will be maintained at the site.

We will identify a pharmacist representative at each site to form a pharmacist-based group who meets monthly to identify strategies to improve processes at each site and to improve use of cangrelor in the MI population according to the established treatment strategy. We will present quarterly feedback reports to the sites that include data regarding the use of cangrelor according to the following parameters: 1) administration of both a bolus and infusion; 2) appropriate timing between infusion and initiation of oral PY212 inhibitor therapy; 3) and administration of the infusion based on clinical trial data and dose package labeling for patients who are able to be transitioned to oral P2Y12 inhibitor therapy shortly after PCI.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • The Brigham and Women's Hospital, Inc.

    Boston, Massachusetts, 02115

  • Kootenai Hospital District dba Kootenai Health

    Coeur d'Alene, Idaho, 83814

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27705

  • University of Florida

    Gainesville, Florida, 32611

  • MedStar Health Research Institute, Inc.

    Hyattsville, Maryland, 20782

  • The Regents of the University of California on behalf of its San Diego campus

    La Jolla, California, 92093

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37323

  • The Trustees of Columbia University in the City of New York

    New York, New York, 10032

  • Christiana Care Health Services, Inc.

    Newark, Delaware, 19713

  • Washington University

    St Louis, Missouri, 63110

Other trials in United States

About this study

The purpose of this registry is to address optimal platelet inhibition during the early management of MI patients prior to coronary angiography or CABG.

Read the detailed description

The CAMEO registry is a multicenter observational registry that will collect information on approximately 5,050 patients with NSTEMI or STEMI treated with cangrelor or an oral P2Y12 inhibitor into the registry.

Phase 1: Each site will abstract data from the medical record for the first 50 patients meeting the inclusion and exclusion criteria treated at the hospital within 4 months prior to study initiation or during the study period.

Phase 2: After Phase 1, all cangrelor-treated patients meeting the inclusion and exclusion criteria will be entered into the registry, and we will begin sampling non-cangrelor patients in a 2:1 cangrelor: non-cangrelor ratio (Phase 2) up to 3000 patients.

Phase 3: We will work with sites on a quality improvement initiative with the current sites to 1) continue enrollment of an additional 2,000 patients; 2) provide feedback reports to both the sites and operators about the use and administration of cangrelor to patients they are treating; 3) utilize a pharmacist-based group with representatives from each site to identify opportunities to improve use of cangrelor according to the established treatment strategy.

Keywords
cangrelor
Medical subject headings
Myocardial Infarction

What participants receive

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

Study groups in NCT04076813
Study groupRoleWhat they receive
STEMI/NSTEMIPatients in the registry will be 18 years of age or older and underwent coronary angiography for a ST-elevation myocardial infarction (STEMI) or NSTEMI Non-ST-elevation myocardial infarction

What is being measured

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

  1. The number of Antiplatelet medications used during hospitalization

    Antiplatelet use, including switching and discontinuation will be measured by medical record report. The medical record report will include medication start and stop dates and times.

    Measured: The time frame is hospitalization through discharge, approximately 3 days

  2. Number of bleeding events during hospitalization as measured by medical record report

    Bleeding event entered from the medical record report.

    Measured: The time frame is hospitalization, up to 7 days post discharge

Timeline

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

  1. First posted3 Sep 2019
  2. Study start16 Oct 2019
  3. Primary completion24 Nov 2025
  4. Study completion15 Dec 2025

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
5,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04076813
Sponsor's protocol ID
Pro00100421
Acronym
CAMEO
Status last verified
Oct 2026
First submitted
30 Aug 2019
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a current plan to share IPD.

Publications

  • Rymer JA, Page C, Alhanti B, Narcisse D, Washam J, Ang L, Bach R, Wimmer N, Kochar A, El-Sabae H, Angiolillo DJ, Bhatt D, Chaturvedi A, Waksman R. TCT-299 cangrelor use in acute myocardial infarction patients awaiting coronary artery bypass grafting. Journal of the American College of Cardiology. 2024;84(18):B68-B69. doi:10.1016/j.jacc.2024.09.353

  • Rymer JA, Bhatt DL, Angiolillo DJ, Diaz M, Garratt KN, Waksman R, Edwards L, Tasissa G, Salahuddin K, El-Sabae H, Dell'Anna C, Davidson-Ray L, Washam JB, Ohman EM, Wang TY. Cangrelor Use Patterns and Transition to Oral P2Y12 Inhibitors Among Patients With Myocardial Infarction: Initial Results From the CAMEO Registry. J Am Heart Assoc. 2022 Jun 7;11(11):e024513. doi: 10.1161/JAHA.121.024513. Epub 2022 May 27.

    PubMed 35621210

  • Rymer J, Alhanti B, Kemp S, Bhatt DL, Kochar A, Angiolillo DJ, Diaz M, Garratt KN, Wimmer NJ, Waksman R, Kirtane AJ, Ang L, Bach R, Barker C, Jenkins R, Basir MB, Sullivan A, El-Sabae H, Brothers L, Ohman EM, Jones WS, Washam JB, Wang TY. Risk of Bleeding Among Cangrelor-Treated Patients Administered Upstream P2Y12 Inhibitor Therapy: The CAMEO Registry. J Soc Cardiovasc Angiogr Interv. 2023 Nov 27;3(2):101202. doi: 10.1016/j.jscai.2023.101202. eCollection 2024 Feb.

    PubMed 39132213

  • Rymer J, Pichan C, Page C, Alhanti B, Bhatt DL, Kochar A, Angiolillo DJ, Diaz M, Wimmer NJ, Waksman R, Ang L, Bach R, Jenkins R, El-Sabae H, Brothers L, Ohman EM, Jones WS, Washam JB, Wang TY, Narcisse D, Basir MB. The Use of Cangrelor in Cardiogenic Shock: Insights from the CAMEO Registry. J Card Fail. 2024 Oct;30(10):1233-1240. doi: 10.1016/j.cardfail.2024.08.003.

    PubMed 39389732

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Chiesi USA, Inc. at 11 sites 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?

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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The number of Antiplatelet medications used during hospitalization (time frame: The time frame is hospitalization through discharge, approximately 3 days). The study lists 2 primary outcomes in all. 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 NCT04076813, which also lists 4 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 28 Oct 2026.

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