Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction (DAPT-SHOCK-AMI)

January 22, 2024 updated by: Zuzana Motovska, Faculty Hospital Kralovske Vinohrady

Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock

Multicenter randomized double blind trial comparing intravenous cangrelor and oral ticagrelor in patients with acute myocardial infarction complicated by initial cardiogenic shock and treated with primary angioplasty.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Randomization to study drugs shall be performed using an online database system for data collection; the assigned arm and the randomisation code will be generated after entering basic patient data based on a predefined randomization scheme.

Concomitant therapy. Acetylsalicylic acid - 500 mg i.v. initial dose, and then 100 mg oral daily dose. Proton pump inhibitor. Additional therapies including further antithrombotic treatment (GP IIb/IIIa inhibitor, heparin) and mechanical support (IABP, ECMO) shall be fully in the competence of the treating doctor.

Electronic database - eCRF. The data from individual follow-up assessments will be entered into an electronic database. The online instrument CLADE-IS will be used for data collection; this instrument provides robust options for electronic case report form (eCRF) design, hierarchical administration of user rights and a user-friendly web interface. The system provides predefined validation rules, conversions of variables, and it takes into account the relationships between variables; user access is controlled by the hierarchical system of user rights and user roles, and database operations are stored for the purpose of audits and tracking of changes. Data safety is ensured through physical security of the servers, authorised access and backup procedures.

Laboratory collections. The efficacy of the antiaggregation drugs cangrelor and ticagrelor will be determined using the flow cytometry analysis of intracellular VASP (vasodilator-stimulated phosphoprotein) phosphorylation.

Study Committees: Executive c., Steering c., Endpoint adjudication c., Data safety monitoring board.

Monitoring. External monitor Clinical Research Associate (CRA)

Definitions. Death is defined as death from all causes. Death from cardiovascular causes is defined as death with evidence of a cardiovascular cause or any death without clear evidence of a non-cardiovascular cause. All deaths are considered as cardiac unless a clear non-cardiac cause can be determined. Any unexpected death (for example, even in patients with a co-existing, potentially fatal non-cardiac disease - cancer, infection) is classified as a death from cardiovascular causes.

Myocardial reinfarction is defined as a new (additional) MI that must differ from the MI based on which the patient was enrolled into the study, satisfying the Third Universal Definition of MI criteria.

Urgent revascularisation of the infarct related artery is defined as a new emergent/urgent revascularisation of the artery intervened upon in the initial procedure, due to repeated manifestations of ischemia occurring after completion of the initial PCI.

Stroke is defined as rapid onset of a new neurological deficit due to an ischemic or haemorrhagic lesion in the central nervous system with the symptoms lasting for at least 24 hours from their onset or resulting in death.

Definitive stent thrombosis is defined according to the Academic Research Consortium criteria.

Bleeding is defined according to the Bleeding Academic Research Consortium (BARC) criteria.

External collaborating centre for statistical analyses. Institute of Biostatistics and Analyses at the Faculty of Medicine of the Masaryk University in Brno, Czech Republic

Study Type

Interventional

Enrollment (Estimated)

550

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Brno, Czechia, 656 91
        • Recruiting
        • St. Anne's University Hospital Brno
        • Contact:
        • Principal Investigator:
          • Ota Hlinomaz, MD PhD
      • Brno, Czechia
        • Recruiting
        • Department of Cardiology, University Hospital Brno-Bohunice
        • Contact:
          • Petr Kala, MD. PhD.
      • Ceske Budejovice, Czechia
        • Recruiting
        • Cardiology department, Regional hospital
        • Contact:
          • Frantisek Tousek, MD. FESC.
        • Contact:
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • University Hospital Hradec Kralove
        • Contact:
        • Principal Investigator:
          • Josef Bis, MD PhD
        • Sub-Investigator:
          • Jaroslav Dusek, MD PhD
      • Jihlava, Czechia
      • Karlovy Vary, Czechia
      • Liberec, Czechia, 460 63
        • Recruiting
        • Krajska Nemocnice Liberec
        • Contact:
        • Principal Investigator:
          • Pavol Tomasov
      • Olomouc, Czechia, 77900
        • Recruiting
        • University Hospital Olomouc
        • Contact:
        • Principal Investigator:
          • Jan Precek, MD PhD
      • Ostrava, Czechia, 70852
        • Recruiting
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Jan Mrozek, MD
      • Pardubice, Czechia
        • Recruiting
        • Department of Cardiology, Regional Hospital,
        • Contact:
          • Jan Matejka, MD. PhD.
        • Contact:
      • Pilsen, Czechia, 304 60
        • Recruiting
        • University Hospital Pilsen
        • Contact:
        • Principal Investigator:
          • Milan Hromadka, MD PhD
      • Prague, Czechia, 12808
        • Recruiting
        • General University Hospital in Prague
        • Principal Investigator:
          • Jan Belohlavek, MD PhD
        • Sub-Investigator:
          • Tomas Kovarnik, MD PhD
        • Contact:
        • Sub-Investigator:
          • Jan Pudil, MD
      • Prague, Czechia, 150 30
        • Recruiting
        • Na Homolce Hospital
        • Contact:
        • Principal Investigator:
          • Petr Ostadal
      • Prague, Czechia, 14021
        • Recruiting
        • Institute of Clinical and Experimental Medicine
        • Contact:
        • Principal Investigator:
          • Jiri Kettner, MD CSc
      • Trinec, Czechia
      • Zlin, Czechia, 762 75
        • Recruiting
        • Regional Hospital T. Bati
        • Contact:
        • Principal Investigator:
          • Zdenek Coufal, MD
        • Sub-Investigator:
          • Martin Griva, MD PhD
      • Ústí Nad Labem, Czechia, 40011
        • Recruiting
        • Masaryk Hospital
        • Contact:
        • Principal Investigator:
          • Pavel Cervinka, MD PhD
        • Sub-Investigator:
          • Vladimir Hrabos, MD
    • Please Select
      • Prague, Please Select, Czechia, 10034
        • Recruiting
        • University Hospital Kralovske Vinohrady
        • Contact:
        • Sub-Investigator:
          • Tamilla Muzafarova, MD
        • Sub-Investigator:
          • Martin Kozel, MD
  • France
      • Paris, France
        • Recruiting
        • Pitié-Salpêtrière Hospital (AP-HP)
        • Contact:
        • Contact:
          • Gilles Montalescot, Prof. MD.
      • Paris, France
        • Recruiting
        • Département de Cardiologie, Hôpital Bichat Assistance Publique Hôpitaux de Paris
        • Contact:
        • Principal Investigator:
          • Gregory Ducrocq, Prof. MD.
  • Germany
  • Poland
      • Bydgoszcz, Poland
        • Recruiting
        • Collegium Medicum University Hospital No. 1
        • Contact:
        • Principal Investigator:
          • Jacek Kubica, Prof. MD. PhD.
        • Sub-Investigator:
          • Piotr Niezgoda, MD.
      • Kraków, Poland
        • Recruiting
        • Jagiellonianan University, University Hospital Krakow
        • Contact:
        • Principal Investigator:
          • Stanislav Bartus, Prof. MD.
        • Sub-Investigator:
          • Artur Dziewierz, Prof. MD.
      • Warsaw, Poland
        • Recruiting
        • Medical University of Warsaw
        • Contact:
        • Contact:
  • Slovakia
      • Banska Bystrica, Slovakia
        • Recruiting
        • Middle-Slovak Institute of Cardiovascular Diseases
        • Contact:
        • Sub-Investigator:
          • Marek Strachan, MD
      • Bratislava, Slovakia
      • Nitra, Slovakia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age over 18 years
  2. Acute myocardial infarction according to the definition of ESC/ACC/AHA, indicated for emergency percutaneous coronary intervention (primary PCI strategy)

  3. Cardiogenic shock present upon admission due to the AMI (≥ 2 of the criteria below are satisfied)24

    1. sBP < 90 mmHg with the absence of hypovolemia
    2. Need of vasopressor and/or inotropic therapy
    3. Presence of the signs of the organ hypoperfusion - cyanosis, cold acra, disorder of consciousness, congestive heart failure
  4. Informed consent form signed.

Exclusion Criteria:

  1. Contraindications of antiplatelet therapy with ticagrelor/cangrelor25

    • Recent (< 6 months) major bleeding
    • Recent (< 1 month) major surgery/injury
    • History of intracranial bleeding
    • History of stroke/TIA
    • Known intolerance to ticagrelor/cangrelor
    • Severe impairment of hepatic function
    • Concomitant administration of strong CYP3A4 inhibitors (for example, ketoconazole, clarithromycin, nefazodone, ritonavir and atazanavir)
  2. Administration of a loading dose of an oral P2Y12 inhibitor prior to admission (clopidogrel ≥ 300 mg, ticagrelor 180 mg, prasugrel 60 mg)
  3. Need of concomitant chronic anticoagulation therapy due to indications such as atrial fibrillation, artificial valve, thromboembolic disease, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cangrelor therapy
Initiation of iv Cangrelor immediately upon arrival of the patient to the cardiac catheterization laboratory and after randomization into the study.
Drug: Cangrelor

Cangrelor: IV bolus 30 μg/kg (application < 1 minute), immediately followed by continuous infusion in the dose of 4 μg/kg/min. To accelerate the initiation of therapy, tables containing calculations of the bolus dose in ml and the speed of infusion therapy for individual weights will be prepared.

  • Cangrelor therapy will be stopped after circulatory stabilization - when sBP > 100 mmHg persists for one hour / when IABP will be terminated / when vasoactive treatment with norepinephrine, dopamine (in the dose ≥ 5 μg/kg/min) will be stopped, but not later than 4 hours after PCI
  • 30 minutes before stopping Cangrelor infusion, administration of initial dose of crushed Ticagrelor 180 mg and then Ticagrelor maintenance dose 90 mg twice a day for 12 months.
Other Names:
  • intravenous P2Y12 inhibitor
Active Comparator: Ticagrelor therapy
Initial dose Ticagrelor immediately upon arrival of the patient to the cardiac catheterization laboratory and after randomization into the study. In patients with a disorder of consciousness, initial dose of Ticagrelor will be administered immediately after nasogastric tube insertion.
Drug: Ticagrelor
Initial dose crushed Ticagrelor 180 mg. Maintenance dose Ticagrelor 90 mg twice daily for 12 months.
Other Names:
  • oral P2Y12 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Clinical Endpoint
Time Frame: Within 30 days after randomization
Combined endpoint defined as Death/Myocardial infarction/Stroke
Within 30 days after randomization
Primary Laboratory endpoint
Time Frame: Periprocedural (periPCI) period
Early achievement of efficient inhibition of ADP-induced platelet aggregation
Periprocedural (periPCI) period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Key secondary net-clinical endpoint
Time Frame: Within 30 days after randomization
Death/Myocardial infarction/Urgent revascularization of the infarct-related artery /Stroke/Major bleeding BARC ≥ 3
Within 30 days after randomization
Key safety endpoint
Time Frame: Within 30 days after randomization
Incidence of bleeding according to the BARC definition
Within 30 days after randomization
Key secondary endpoint
Time Frame: Within 30 days and one year after randomization
Cardiovascular death/Myocardial infarction/Urgent revascularization/Heart failure
Within 30 days and one year after randomization
Secondary endpoint
Time Frame: Within 30 days and one year after randomization
Individual components of the primary clinical endpoint
Within 30 days and one year after randomization
Other secondary endpoint
Time Frame: Within 30 days and one year after randomization
Death from cardiovascular causes
Within 30 days and one year after randomization
Secondary outcome
Time Frame: Within 30 days after randomization
Definite stent thrombosis
Within 30 days after randomization
Secondary safety outcome
Time Frame: Within 30 days after randomization
Delaying the surgery due to bleeding
Within 30 days after randomization

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-specified Outcome
Time Frame: Index event Hospitalization
Duration of vasoactive pharmacotherapy and/or mechanical circulatory support
Index event Hospitalization
Other Pre-specified Outcome
Time Frame: Index event Hospitalization
Duration of hospitalisation
Index event Hospitalization
Cost analysis
Time Frame: Within 30 day and one year after randomization
Cost-effectiveness analysis
Within 30 day and one year after randomization
MRI sub-study endpoints
Time Frame: Within one year after randomization
Magnetic Resonance Imaging sub-study
Within one year after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty Hospital Kralovske Vinohrady

Collaborators

Charles University, Czech Republic

Investigators

  • Principal Investigator: Zuzana Motovska, MD. PhD., University Hospital Kralovske Vinohrady, Prague, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 29, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13062017-23-1
  • 2018-002161-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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