Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03551964
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
Charles University, Czech Republic
Information provided by (Responsible Party):
Zuzana Motovska, Faculty Hospital Kralovske Vinohrady

Tracking Information
First Submitted Date  ICMJE May 29, 2018
First Posted Date  ICMJE June 11, 2018
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE August 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Clinical endpoint [ Time Frame: Within 30 days after randomization ]
    Combined endpoint defined as Death/Myocardial infarction/Stroke
  • Laboratory endpoint [ Time Frame: Periprocedural (periPCI) period ]
    Early achievement of efficient inhibition of ADP-induced platelet aggregation. Efficient inhibition is defined by the Platelet Reactivity Index (determined based on the VASP protein phosphorylation) < 50%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Key secondary net-clinical endpoint [ Time Frame: Within 30 days after randomization ]
    Death/Myocardial infarction/Urgent revascularisation of the infarct-related artery /Stroke/Major bleeding BARC ≥ 3
  • Key safety endpoint [ Time Frame: Within 30 days after randomization ]
    Incidence of bleeding according to the BARC definition
  • Other secondary endpoint [ Time Frame: Within 30 days and one year after randomization ]
    Individual components of the primary clinical endpoint
  • Other secondary endpoint [ Time Frame: Within 30 days and one year after randomization. ]
    Death from cardiovascular causes
  • Secondary endpoint [ Time Frame: Within 30 days after randomization ]
    Definite stent thrombosis
  • Secondary endpoint [ Time Frame: Within 30 days after randomization ]
    Duration of vasoactive pharmacotherapy and/or mechanical circulatory support (norepinephrine/epinephrine/dopamine in the dose > 5 μg/kg/min/IABP/ECMO),
  • Secondary endpoint [ Time Frame: Index event Hospitalization ]
    Duration of hospitalisation
  • Secondary endpoint [ Time Frame: Within 30 days after randomization ]
    Delaying the surgery due to bleeding
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 8, 2018)
Cost analysis [ Time Frame: Within 30 day after randomization ]
Cost-effectiveness analysis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction
Official Title  ICMJE Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myocardial Infarction
  • Cardiogenic Shock
Intervention  ICMJE
  • 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 Name: intravenous P2Y12 inhibitor
  • Drug: Ticagrelor
    Initial dose crushed Ticagrelor 180 mg. Maintenance dose Ticagrelor 90 mg twice daily for 12 months.
    Other Name: oral P2Y12 inhibitor
Study Arms  ICMJE
  • Experimental: Cangrelor therapy
    Initiation of iv Cangrelor immediately upon arrival of the patient to the cardiac catheterization laboratory and after randomization into the study.
    Intervention: Drug: Cangrelor
  • 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.
    Intervention: Drug: Ticagrelor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2018)
304
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Zuzana Motovska, MD. PhD. +420731573253 motovska.zuzana@gmail.com
Listed Location Countries  ICMJE Czechia,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03551964
Other Study ID Numbers  ICMJE 13062017-23-1
2018-002161-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zuzana Motovska, Faculty Hospital Kralovske Vinohrady
Study Sponsor  ICMJE Faculty Hospital Kralovske Vinohrady
Collaborators  ICMJE Charles University, Czech Republic
Investigators  ICMJE
Principal Investigator: Zuzana Motovska, MD. PhD. University Hospital Kralovske Vinohrady, Prague, Czech Republic
PRS Account Faculty Hospital Kralovske Vinohrady
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP