NCT04076813Completed
Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
The purpose of this registry is to address optimal platelet inhibition during the early management of MI patients prior to coronary angiography or CABG.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 5050 (actual)
- First submitted
- 30 Aug 2019
- Start date
- 16 Oct 2019
- Primary completion date
- 24 Nov 2025
- Lead sponsor
- Chiesi USA, Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT04076813
What you commit to
- Study type: Observational
- Participants enrolled: 5050
- From 16 Oct 2019 to the primary completion date, 24 Nov 2025
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Age
- 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.
Other
- Phase 3 Eligibility Criteria:
Criteria the registry did not label
- 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:
- 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.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Brigham and Women's Hospital, Inc. Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Kootenai Hospital District dba Kootenai Health Coordinator of this site? Confirm its status | Coeur d'Alene | United States | Unknown status |
| Henry Ford Health System Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Medstar Health Research Institute, Inc Coordinator of this site? Confirm its status | Hyattsville | United States | Unknown status |
| The Regents of the University of California on behalf of its San Diego campus Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Christiana Care Health Services, Inc. Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| The Trustees of Columbia University in the City of New York Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Washington University Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.