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

Acute Myocardial Infarction Clinical Trial

— CAN-SHOCK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611607
• Other study ID #: CAN-SHOCK
• Status: Completed
• Start date: May 4, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: March 2022
• Source: IHF GmbH - Institut für Herzinfarktforschung
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Shock, Cardiogenic

Locations

Country	Name	City	State
Austria	Universitätsklinikum Graz	Graz
Austria	Klinik Ottakring	Wien
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

Sponsors (2)

Lead Sponsor	Collaborator
IHF GmbH - Institut für Herzinfarktforschung	Ferrer Internacional S.A.

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definite stent thrombosis	Rate of stent thromboses	from procedure for index MI up to 48 hours
Primary	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	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
Secondary	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
Secondary	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
Secondary	Mortality	Rate of death	from procedure for index MI until discharge from hospital; up to 30 days