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OpenTrials
Completed

NCT Number: NCT04611607

Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Graz, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

IHF GmbH - Institut für Herzinfarktforschung

Other

Collaborators

  • Ferrer Internacional S.A.

Registry information

Acronym: CAN-SHOCK

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2020
Registry last updated
Jul 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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