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Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock (CAN-SHOCK)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04611607
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : July 27, 2022
Sponsor:
Collaborator:
Ferrer Internacional S.A.
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung

Brief Summary:
This registry will provide information about the efficacy and safety of cangrelor in a very high-risk group of patients with acute myocardial infarction undergoing PCI. It will not only include patients with cardiogenic shock, but a variety of patients not able to swallow tablets, such as those after CPR and/or with invasive or non-invasive ventilation. Therefore it will provide information about the use of cangrelor beyond the current knowledge.

Condition or disease
Acute Myocardial Infarction

Detailed Description:

This registry is a non-interventional, multicentre, retrospective cohort study in patients with acute myocardial infarction undergoing PCI after CRP, ventilated and/or with cardiogenic shock.

The study is purely observational; data will be documented retrospectively based on available medical records. No additional data will be collected, no study-related treatment will be initiated.

About 10 - 20 high-volume PCI clinics in Germany treating patients with myocardial infarction are eligible for participation. Participating sites will be given a maximum of 6 months for retrospectively documenting eligible patients.

Eligible are all patients with acute myocardial infarction (STEMI, NSTEMI) who underwent PCI after CRP, ventilated and/or with cardiogenic shock and were treated with cangrelor during index procedure. It is planned to enrol about 400 patients in total. Patient characteristics, procedural details and clinical events occurring during the period between index MI and discharge or death (whichever came first) will be documented based on the relevant existing medical charts of the patients.

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Study Type : Observational
Actual Enrollment : 303 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
Actual Study Start Date : May 4, 2021
Actual Primary Completion Date : June 7, 2022
Actual Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock




Primary Outcome Measures :
  1. Definite stent thrombosis [ Time Frame: from procedure for index MI up to 48 hours ]
    Rate of stent thromboses

  2. Recurrent myocardial infarction [ Time Frame: from procedure for index MI up to 48 hours ]
    Rate of recurrent myocardial infarction according to the universal definition of MI


Secondary Outcome Measures :
  1. Definite stent thrombosis [ Time Frame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days ]
    Rate of stent thromboses

  2. Recurrent myocardial infarction [ Time Frame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days ]
    Rate of recurrent myocardial infarction according to the universal definition of MI

  3. Bleeding complications [ Time Frame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days ]
    Rate of bleeding complication according to BARC definition

  4. Mortality [ Time Frame: from procedure for index MI until discharge from hospital; up to 30 days ]
    Rate of death



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:   Non-Probability Sample
Study Population
Patients with acute myocardial infarction (STEMI, NSTEMI) undergoing PCI and treated with cangrelor after CPR / in cardiogenic shock / with mechanical or non-invasive ventilation
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Acute Myocardial infarction (NSTEMI or STEMI)
  • PCI with stent implantation
  • Treatment with cangrelor during index procedure
  • At least one of the following criteria:
  • CPR prior to PCI
  • Cardiogenic shock
  • Heart failure with the need for mechanical or non-invasive ventila-tion

Exclusion Criteria:

No explicit medical exclusion criteria are stated to avoid selection bias.


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): NCT04611607


Locations
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Austria
Universitätsklinikum Graz
Graz, Austria
Klinik Ottakring
Wien, Austria
Germany
Fürst-Stirum Klinikum Bruchsal
Bruchsal, Germany
Universitätsklinikum Freiburg
Freiburg, Germany
Klinikum Leverkusen
Leverkusen, Germany
Klinikum Ludwigshafen
Ludwigshafen, Germany
Universitätsklinikum Mannheim
Mannheim, Germany
Hegau-Bodensee Klinikum Singen
Singen, Germany
Krankenhaus Maria-Hilf
Stadtlohn, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
Ferrer Internacional S.A.
Investigators
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Principal Investigator: Uwe Zeymer, Prof Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung
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Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT04611607    
Other Study ID Numbers: CAN-SHOCK
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: July 27, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Myocardial Infarction
Shock, Cardiogenic
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Shock