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

NCT ID: NCT04611607

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

303 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-04

Study Completion Date

2022-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ferrer Internacional S.A.

INDUSTRY

Sponsor Role collaborator

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Uwe Zeymer, Prof

Role: PRINCIPAL_INVESTIGATOR

Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsklinikum Graz

Graz, , Austria

Site Status

Klinik Ottakring

Vienna, , Austria

Site Status

Fürst-Stirum Klinikum Bruchsal

Bruchsal, , Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status

Klinikum Leverkusen

Leverkusen, , Germany

Site Status

Klinikum Ludwigshafen

Ludwigshafen, , Germany

Site Status

Universitätsklinikum Mannheim

Mannheim, , Germany

Site Status

Hegau-Bodensee Klinikum Singen

Singen, , Germany

Site Status

Krankenhaus Maria-Hilf

Stadtlohn, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CAN-SHOCK

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dutch Cangrelor Registry
NCT04138641 COMPLETED
A Study of VentriGel in Post-MI Patients
NCT02305602 COMPLETED PHASE1