Clinical trial NCT04611607: Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
Official title: Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: IHF GmbH - Institut für Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Ferrer Internacional S.A.
First posted: 2020-11-02
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Definite stent thrombosis
timeFrame: from procedure for index MI up to 48 hours
measure: Recurrent myocardial infarction
timeFrame: from procedure for index MI up to 48 hours
Secondary outcomes:
measure: Definite stent thrombosis
timeFrame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
measure: Recurrent myocardial infarction
timeFrame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
measure: Bleeding complications
timeFrame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
measure: Mortality
timeFrame: from procedure for index MI until discharge from hospital; up to 30 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Universitätsklinikum Graz
city: Wien
country: Austria
facility: Klinik Ottakring
city: Bruchsal
country: Germany
facility: Fürst-Stirum Klinikum Bruchsal
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
city: Ludwigshafen
country: Germany
facility: Klinikum Ludwigshafen
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Singen
country: Germany
facility: Hegau-Bodensee Klinikum Singen
city: Stadtlohn
country: Germany
facility: Krankenhaus Maria-Hilf
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung
name: Uwe Zeymer, Prof
role: PRINCIPAL_INVESTIGATOR
References: