Status:
ACTIVE_NOT_RECRUITING
Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
Lead Sponsor:
Chiesi USA, Inc.
Collaborating Sponsors:
Duke University
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Brief 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.
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...
Eligibility Criteria
Inclusion
- Phase 1
- 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
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
5050 Patients enrolled
Trial Details
Trial ID
NCT04076813
Start Date
October 16 2019
End Date
June 30 2025
Last Update
June 13 2025
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
The Regents of the University of California on behalf of its San Diego campus
La Jolla, California, United States, 92093
2
Christiana Care Health Services, Inc.
Newark, Delaware, United States, 19713
3
University of Florida
Gainesville, Florida, United States, 32611
4
Kootenai Hospital District dba Kootenai Health
Coeur d'Alene, Idaho, United States, 83814