Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

NCT04076813 | Active Not Recruiting

• 1 other identifier: Pro00100421
• Study Type: observational
• Target: 5,050
• Locations: 1 country
• Sites: 11

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.

Conditions

Myocardial Infarction

Keywords

cangrelor

Outcome Measures

Primary Outcomes (2)

• 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.

  The time frame is hospitalization through discharge, approximately 3 days

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

  Bleeding event entered from the medical record report.

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

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi USA, Inc.: lead
• Duke University: collaborator

Study Sites (11)

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

La Jolla, California, 92093, United States

Location

Christiana Care Health Services, Inc.

Newark, Delaware, 19713, United States

Location

University of Florida

Gainesville, Florida, 32611, United States

Location

Kootenai Hospital District dba Kootenai Health

Coeur d'Alene, Idaho, 83814, United States

Location

MedStar Health Research Institute, Inc.

Hyattsville, Maryland, 20782, United States

Location

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, 02115, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The Trustees of Columbia University in the City of New York

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37323, United States

Location

Related Publications (3)

• 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.

  PMID: 35621210 BACKGROUND

• 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.

  PMID: 39132213 BACKGROUND

• 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.

  PMID: 39389732 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Jennifer Rymer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Jeffrey Washam

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: September 3, 2019
• Study Start: October 16, 2019
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)