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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

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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

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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
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Contact: Zuzana Motovska, MD. PhD. +420731573253 motovska.zuzana@gmail.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
Faculty Hospital Kralovske Vinohrady
Charles University, Czech Republic
Investigators
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Principal Investigator: Zuzana Motovska, MD. PhD. University Hospital Kralovske Vinohrady, Prague, Czech Republic

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Responsible Party: Zuzana Motovska, Zuzana Motovska MD PHD, Faculty Hospital Kralovske Vinohrady
ClinicalTrials.gov Identifier: NCT03551964    
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

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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:
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Myocardial Infarction
Shock, Cardiogenic
Infarction
Shock
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Cangrelor
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