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Active, not recruitingNCT04076813CAMEOUpdated Jun 13, 2025

Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

An observational study in Myocardial Infarction, sponsored by Chiesi USA, Inc.. Active, not recruiting at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.

Sponsored by Chiesi USA, Inc. · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
5,050
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Myocardial Infarction

Keywords

  • cangrelor
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 5,050 is above the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

This is the only study on the registry with Chiesi USA, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Eligibility criteria

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.
  2. 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.

05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
5,050 participants (actual)
Patient registry
No

Groups and cohorts

  • STEMI/NSTEMI

    Patients 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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

07

Study locations

11 sites
  • The Regents of the University of California on behalf of its San Diego campus
    La Jolla, California 92093, United States
  • Christiana Care Health Services, Inc.
    Newark, Delaware 19713, United States
  • University of Florida
    Gainesville, Florida 32611, United States
  • Kootenai Hospital District dba Kootenai Health
    Coeur d'Alene, Idaho 83814, United States
  • MedStar Health Research Institute, Inc.
    Hyattsville, Maryland 20782, United States
  • The Brigham and Women's Hospital, Inc.
    Boston, Massachusetts 02115, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Washington University
    St. Louis, Missouri 63110, United States
  • The Trustees of Columbia University in the City of New York
    New York, New York 10032, United States
  • Duke University
    Durham, North Carolina 27705, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37323, United States
08

References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: No — There is not a current plan to share IPD.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04076813
Lead sponsor
Chiesi USA, Inc.
Collaborators
Duke University
Responsible party
Sponsor
First posted
Sep 3, 2019
Start date
Oct 16, 2019
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jun 13, 2025

Study contacts

Jennifer Rymer, MD
principal investigator · Duke University
Jeffrey Washam
principal investigator · Duke University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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