NCT04611607

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

May 4, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2022

Completed
Last Updated

July 27, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

October 15, 2020

Last Update Submit

July 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Definite stent thrombosis

    from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days

  • Recurrent myocardial infarction

    from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days

  • Bleeding complications

    from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days

  • Mortality

    from procedure for index MI until discharge from hospital; up to 30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Universitätsklinikum Graz

Graz, Austria

Location

Klinik Ottakring

Vienna, Austria

Location

Fürst-Stirum Klinikum Bruchsal

Bruchsal, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Klinikum Leverkusen

Leverkusen, Germany

Location

Klinikum Ludwigshafen

Ludwigshafen, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Hegau-Bodensee Klinikum Singen

Singen, Germany

Location

Krankenhaus Maria-Hilf

Stadtlohn, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Study Officials

  • Uwe Zeymer, Prof

    Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2020

First Posted

November 2, 2020

Study Start

May 4, 2021

Primary Completion

June 7, 2022

Study Completion

June 7, 2022

Last Updated

July 27, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations