Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 27 for:    cangrelor

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

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Cardiogenic Shock Drug: Cangrelor Drug: Ticagrelor Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cangrelor Versus Ticagrelor In Patients With Acute Myocardial Infarction Complicated With Initial Cardiogenic Shock
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack Shock

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 Name: 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 Name: oral P2Y12 inhibitor




Primary Outcome Measures :
  1. Clinical endpoint [ Time Frame: Within 30 days after randomization ]
    Combined endpoint defined as Death/Myocardial infarction/Stroke

  2. 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%.


Secondary Outcome Measures :
  1. 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

  2. Key safety endpoint [ Time Frame: Within 30 days after randomization ]
    Incidence of bleeding according to the BARC definition

  3. Other secondary endpoint [ Time Frame: Within 30 days and one year after randomization ]
    Individual components of the primary clinical endpoint

  4. Other secondary endpoint [ Time Frame: Within 30 days and one year after randomization. ]
    Death from cardiovascular causes

  5. Secondary endpoint [ Time Frame: Within 30 days after randomization ]
    Definite stent thrombosis

  6. 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),

  7. Secondary endpoint [ Time Frame: Index event Hospitalization ]
    Duration of hospitalisation

  8. Secondary endpoint [ Time Frame: Within 30 days after randomization ]
    Delaying the surgery due to bleeding


Other Outcome Measures:
  1. Cost analysis [ Time Frame: Within 30 day after randomization ]
    Cost-effectiveness analysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551964


Contacts
Layout table for location contacts
Contact: Zuzana Motovska, MD. PhD. +420731573253 motovska.zuzana@gmail.com

Locations
Layout table for location information
Czechia
University Hospital Kralovske Vinohrady Recruiting
Prague, Please Select, Czechia, 10034
Contact: Zuzana Motovska, MD PhD    +420731573253    motovska.zuzana@gmail.com   
Sub-Investigator: Jiri Knot, MD PhD         
Sub-Investigator: Jaroslav Ulman, MD         
St. Anne's University Hospital Brno Recruiting
Brno, Czechia, 656 91
Contact: Ota Hlinomaz, MD PhD    +42054318 5470    ota.hlinomaz@fnusa.cz   
Principal Investigator: Ota Hlinomaz, MD PhD         
Department of Cardiology, University Hospital Brno-Bohunice Recruiting
Brno, Czechia
Contact: Petr Kala, MD. PhD.         
Cardiology Department, Regional Hospital Recruiting
Ceske Budejovice, Czechia
Contact: Frantisek Tousek, MD. FESC.         
Contact       tousek@nemcb.cz   
University Hospital Hradec Králové Recruiting
Hradec Králové, Czechia, 500 05
Contact: Josef Bis, MD PhD    +420495834239    josef.bis@fnhk.cz   
Principal Investigator: Josef Bis, MD PhD         
Sub-Investigator: Jaroslav Dusek, MD PhD         
Cardiology department, Regional hospital Not yet recruiting
Jihlava, Czechia
Contact: Zdenek Klimsa, MD       klimsaz@nemji.cz   
Contact: Petr Simek, MD       simekp@nemji.cz   
Cardiocenter, Regional Hospital Recruiting
Karlovy Vary, Czechia
Contact: Alexander Schee, MD         
Contact       alexandr.schee@gmail.com   
Krajská nemocnice Liberec Recruiting
Liberec, Czechia, 460 63
Contact: Jiri Karasek, MD    +420 485 312 646    jirikarry@gmail.com   
Principal Investigator: Jiri Karasek         
University Hospital Olomouc Recruiting
Olomouc, Czechia, 77900
Contact: Jan Precek, MD PhD    +420 588 443 214    jan.precek@seznam.cz   
Principal Investigator: Jan Precek, MD PhD         
University Hospital Ostrava Recruiting
Ostrava, Czechia, 70852
Contact: Jan Mrozek, MD    +420 596 920 115    honzamrozek@email.cz   
Principal Investigator: Jan Mrozek, MD         
Department of Cardiology, Regional Hospital, Recruiting
Pardubice, Czechia
Contact: Jan Matejka, MD. PhD.         
Contact       jan.matejka@nempk.cz   
University Hospital Pilsen Recruiting
Pilsen, Czechia, 304 60
Contact: Milan Hromadka, MD PhD    +00420377 103 3166    hromadka@fnplzen.cz   
Principal Investigator: Milan Hromadka, MD PhD         
General University Hospital in Prague Recruiting
Prague, Czechia, 12808
Contact: Jana Smalcova, MD    +420224962504    jana.smalcova@vfn.cz   
Sub-Investigator: Jana Smalcova, MD         
Principal Investigator: Jan Belohlavek, MD PhD         
Sub-Investigator: Tomas Kovarnik, MD PhD         
Institute of Clinical and Experimental Medicine Recruiting
Prague, Czechia, 14021
Contact: Jiri Kettner, MD CSc    +42023 605 5007    jiri.kettner@ikem.cz   
Principal Investigator: Jiri Kettner, MD CSc         
Na Homolce Hospital Recruiting
Prague, Czechia, 150 30
Contact: Petr Ostadal, MD PhD    +420 257 272 208    petr.ostadal@homolka.cz   
Principal Investigator: Petr Ostadal         
Cardiocenter, Hospital Podlesi Recruiting
Trinec, Czechia
Contact: Libor Sknouril, MD. PhD.         
Contact       libor.sknouril@nempodlesi.cz   
Regional Hospital T. Bati Recruiting
Zlin, Czechia, 762 75
Contact: Zdenek Coufal, MD    +420577 552 138    coufal@bnzlin.cz   
Principal Investigator: Zdenek Coufal, MD         
Sub-Investigator: Martin Griva, MD PhD         
Masaryk Hospital Recruiting
Ústí Nad Labem, Czechia, 40011
Contact: Pavel Cervinka, MD PhD    +420 477 117 886    pavel.cervinka@kzcr.eu   
Principal Investigator: Pavel Cervinka, MD PhD         
Sub-Investigator: Vladimir Hrabos, MD         
Slovakia
Cardiocentre Not yet recruiting
Nitra, Slovakia
Contact: Peter Obona, MD       pobona@centrum.sk   
Contact: Andrea Andrasova, MD       andrea.andrasova@gmail.com   
Sponsors and Collaborators
Faculty Hospital Kralovske Vinohrady
Charles University, Czech Republic
Investigators
Layout table for investigator information
Principal Investigator: Zuzana Motovska, MD. PhD. University Hospital Kralovske Vinohrady, Prague, Czech Republic

Layout table for additonal information
Responsible Party: Zuzana Motovska, Zuzana Motovska MD PHD, Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT03551964     History of Changes
Other Study ID Numbers: 13062017-23-1
2018-002161-19 ( EudraCT Number )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019

Layout table for additional information
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
Keywords provided by Zuzana Motovska, Faculty Hospital Kralovske Vinohrady:
Acute myocardial infarction
Cardiogenic shock
Primary percutaneous coronary intervention
Dual antiplatelet therapy
Cangrelor
Ticagrelor
Additional relevant MeSH terms:
Layout table for MeSH terms
Cangrelor
Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs