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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04076813
Recruitment Status : Recruiting
First Posted : September 2, 2019
Last Update Posted : October 18, 2019
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date August 30, 2019
First Posted Date September 2, 2019
Last Update Posted Date October 18, 2019
Actual Study Start Date October 16, 2019
Estimated Primary Completion Date September 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 30, 2019)
  • The number of Antiplatelet medications used during hospitalization [ Time Frame: 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.
  • Number of bleeding events during hospitalization as measured by medical record report [ Time Frame: The time frame is hospitalization, up to 7 days post discharge ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04076813 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
Official Title Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population ≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI.
Condition Myocardial Infarction
Intervention Not Provided
Study Groups/Cohorts STEMI/NSTEMI
Patients in the registry will be 18 years of age or older and underwent coronary angiography for a ST-evelvation myocardial infarction (STEMI) or NSTEMI Non-ST-evelvation myocardial infarction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 30, 2019)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 30, 2022
Estimated Primary Completion Date September 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

For the first 200 patients in the registry, 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.

Exclusion 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.
  • 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.
  • The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Tracy Hofmann 919-668-7544 tracy.hofmann@duke.edu
Contact: Linda Davidson-Ray 919-668-8724 linda.davidson.ray@duke.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04076813
Other Study ID Numbers Pro00100421
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is not a current plan to share IPD.
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Tracy Wang, MD Duke University
PRS Account Duke University
Verification Date August 2019