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Trial record 24 of 27 for:    cangrelor

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 : Not yet recruiting
First Posted : September 2, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Duke University

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
Myocardial Infarction

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
Estimated Study Start Date : September 23, 2019
Estimated Primary Completion Date : September 23, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Cangrelor

Group/Cohort
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



Primary Outcome Measures :
  1. 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.

  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
≥ 18 years of age and underwent coronary angiography for a STEMI or NSTEMI.
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:

    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.
      • The patient underwent coronary angiography followed by CABG during the index MI admission and received any P2Y12 inhibitor within 7 days prior to CABG.
    2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04076813


Contacts
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Contact: Tracy Hofmann 919-668-7544 tracy.hofmann@duke.edu
Contact: Linda Davidson-Ray 919-668-8724 linda.davidson.ray@duke.edu

Sponsors and Collaborators
Duke University
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Tracy Wang, MD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04076813     History of Changes
Other Study ID Numbers: Pro00100421
First Posted: September 2, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a current plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cangrelor
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs