Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

NCT ID: NCT04076813

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2025-06-30

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 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.

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility Criteria

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.

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 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 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

Phase 3 Eligibility Criteria:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Chiesi USA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Rymer, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jeffrey Washam

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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

La Jolla, California, United States

Christiana Care Health Services, Inc.

Newark, Delaware, United States

University of Florida

Gainesville, Florida, United States

Kootenai Hospital District dba Kootenai Health

Coeur d'Alene, Idaho, United States

MedStar Health Research Institute, Inc.

Hyattsville, Maryland, United States

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

The Trustees of Columbia University in the City of New York

New York, New York, United States

Duke University

Durham, North Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 35621210 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39132213 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 39389732 (View on PubMed)

Other Identifiers

Pro00100421

Identifier Type: -

Identifier Source: org_study_id