Acute Myocardial InfarctionCAN-SHOCKNCT04611607
Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
An observational study of Acute Myocardial Infarction, run by IHF GmbH - Institut für Herzinfarktforschung at 10 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- How many people
- 303 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 4 May 2021to 7 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- No explicit medical exclusion criteria are stated to avoid selection bias.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany8 sites
Fürst-Stirum Klinikum Bruchsal
Bruchsal
Universitätsklinikum Freiburg
Freiburg im Breisgau
Klinikum Leverkusen
Leverkusen
Klinikum Ludwigshafen
Ludwigshafen
Universitätsklinikum Mannheim
Mannheim
Hegau-Bodensee Klinikum Singen
Singen
Krankenhaus Maria-Hilf
Stadtlohn
Universitätsklinikum Tübingen
Tübingen
About this study
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.
Read the 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.
- Conditions
- Acute Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Definite stent thrombosis
Rate of stent thromboses
Measured: from procedure for index MI up to 48 hours
Recurrent myocardial infarction
Rate of recurrent myocardial infarction according to the universal definition of MI
Measured: from procedure for index MI up to 48 hours
Secondary outcomes (4)
Definite stent thrombosis
Rate of stent thromboses
Measured: 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
Measured: 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
Measured: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Mortality
Rate of death
Measured: from procedure for index MI until discharge from hospital; up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start4 May 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Collaborators
- Ferrer Internacional S.A.
- Responsible party
- Sponsor
- Investigators
- Uwe Zeymer, Prof, Principal investigator, Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611607
- Sponsor's protocol ID
- CAN-SHOCK
- Acronym
- CAN-SHOCK
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2020
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cangrelor in Patients With Acute Myocardial Infarction Undergoing PCI After CPR, Ventilated or Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT04611607
- Acronym / sponsor ID
- CAN-SHOCK / CAN-SHOCK
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Collaborators
- Ferrer Internacional S.A.
- Study start
- 4 May 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (1 listed)
- No explicit medical exclusion criteria are stated to avoid selection bias.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Definite stent thrombosis
Time frame: from procedure for index MI up to 48 hours
Rate of stent thromboses
Recurrent myocardial infarction
Time frame: from procedure for index MI up to 48 hours
Rate of recurrent myocardial infarction according to the universal definition of MI
4 secondary outcomes
Definite stent thrombosis
Time frame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Recurrent myocardial infarction
Time frame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Bleeding complications
Time frame: from procedure for index MI until discharge from hospital or intrahosptal death, whichever came first; up to 30 days
Mortality
Time frame: from procedure for index MI until discharge from hospital; up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Zeymer, Prof principal investigator
Klinikum Ludwigshafen ; Stiftung IHF Institut für Herzinfarktforschung
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by IHF GmbH - Institut für Herzinfarktforschung at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definite stent thrombosis (time frame: from procedure for index MI up to 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.