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CAMEO: Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry

Sponsor
Chiesi USA, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04076813
Collaborator
Duke University (Other)
3,000
Enrollment
11
Locations
36.5
Anticipated Duration (Months)
272.7
Patients Per Site
7.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The CAMEO registry is a multicenter observational registry that will collect information on 3,000 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 treated at the hospital no later than 1 month from the discharge date will be entered into the registry, and we will begin sampling non-cangrelor patients in a 2:1 cangrelor: non-cangrelor ratio.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
    Actual Study Start Date :
    Oct 16, 2019
    Anticipated Primary Completion Date :
    Oct 31, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. The number of Antiplatelet medications used during hospitalization [The time frame is hospitalization through discharge, approximately 3 days]

      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.

    2. Number of bleeding events during hospitalization as measured by medical record report [The time frame is hospitalization, up to 7 days post discharge]

      Bleeding event entered from the medical record report.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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
    5 MedStar Health Research Institute, Inc. Hyattsville Maryland United States 20782
    6 The Brigham and Women's Hospital, Inc. Boston Massachusetts United States 02115
    7 Henry Ford Health System Detroit Michigan United States 48202
    8 Washington University Saint Louis Missouri United States 63110
    9 The Trustees of Columbia University in the City of New York New York New York United States 10032
    10 Duke University Durham North Carolina United States 27705
    11 Vanderbilt University Medical Center Nashville Tennessee United States 37323

    Sponsors and Collaborators

    • Chiesi USA, Inc.
    • Duke University

    Investigators

    • Principal Investigator: Tracy Wang, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chiesi USA, Inc.
    ClinicalTrials.gov Identifier:
    NCT04076813
    Other Study ID Numbers:
    • Pro00100421
    First Posted:
    Sep 3, 2019
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chiesi USA, Inc.
    cangrelor
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Jun 16, 2022