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

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 303

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Universitätsklinikum Graz
  • Wien, Austria
    • Klinik Ottakring
• Germany
  • Bruchsal, Germany
    • Fürst-Stirum Klinikum Bruchsal
  • Freiburg, Germany
    • Universitätsklinikum Freiburg
  • Leverkusen, Germany
    • Klinikum Leverkusen
  • Ludwigshafen, Germany
    • Klinikum Ludwigshafen
  • Mannheim, Germany
    • Universitätsklinikum Mannheim
  • Singen, Germany
    • Hegau-Bodensee Klinikum Singen
  • Stadtlohn, Germany
    • Krankenhaus Maria-Hilf
  • Tübingen, Germany
    • Universitätsklinikum Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definite stent thrombosis	Rate of stent thromboses	from procedure for index MI up to 48 hours
Recurrent myocardial infarction	Rate of recurrent myocardial infarction according to the universal definition of MI	from procedure for index MI up to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Definite stent thrombosis	Rate of stent thromboses	from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Recurrent myocardial infarction	Rate of recurrent myocardial infarction according to the universal definition of MI	from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Bleeding complications	Rate of bleeding complication according to BARC definition	from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Mortality	Rate of death	from procedure for index MI until discharge from hospital; up to 30 days

Collaborators and Investigators

• Sponsor: IHF GmbH - Institut für Herzinfarktforschung
• Collaborators: Ferrer Internacional S.A.
• Investigators: Principal Investigator: Uwe Zeymer, Prof, Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (Actual): November 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Shock; Myocardial Infarction; Infarction; Shock, Cardiogenic
• Other Study ID Numbers: CAN-SHOCK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No