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Cangrelor vs. Ticagrelor for Early Platelet Inhibition in STEMI (CanTi)

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ClinicalTrials.gov Identifier: NCT03182855
Recruitment Status : Not yet recruiting
First Posted : June 9, 2017
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Jacob Sørensen, University of Aarhus

Brief Summary:

This randomized, controlled trial compares the anti-thrombotic effect of cangrelor and ticagrelor on platelet activity in patients with acute ST-elevation myocardial infarction.

Patients will receive either prehospital ticagrelor (180 mg - crushed) or in-hospital cangrelor (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two hours) followed by 180 mg ticagrelor.

The primary study end-point is platelet reactivity at sheath insertion, at the end of the PCI procedure (before sheath removal) and two hours after PCI is initiated. The secondary end-point is the proportion of patients with inappropriate or harmful P2Y12 administration.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Myocardial Infarction STEMI - ST Elevation Myocardial Infarction Drug: Ticagrelor Drug: Cangrelor Tetrasodium Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized trial. No blinding
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cangrelor vs. Ticagrelor for Early Platelet Inhibition in ST-elevation Myocardial Infarction
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Active Comparator: Prehospital ticagrelor

Ticagrelor 180 mg orally administered in the ambulance as soon as possible after inclusion and before coronary angiography. The two pills are chewed and swallowed with a glass of water.

In both groups heparin and bivalirudin will be administered as part of routine therapy. In hemodynamically compromised patients with a high thrombus load a glycoprotein IIb/IIIa inhibitor may be used as bail-out therapy (these patients will be excluded). These drugs are not deemed to be study medication.

Drug: Ticagrelor
ADP-receptor blocker. Oral formulation. Standard Therapy in Acute Myocardial Infarction. Administered in the ambulance in arm 1 and in the hospital (catheterization laboratory) in arm 2.
Other Names:
  • Brilique
  • Brilinta

Active Comparator: Inhospital cangrelor tetrasodium

Ticagrelor 180 mg orally in combination with cangrelor intravenously (bolus 30 μg/kg within 1 minute followed by infusion (4 μg/kg/minute) for two hours) both administered immediately after coronary angiography, when PPCI is indicated.

In both groups heparin and bivalirudin will be administered as part of routine therapy. In hemodynamically compromised patients with a high thrombus load a glycoprotein IIb/IIIa inhibitor may be used as bail-out therapy (these patients will be excluded). These drugs are not deemed to be study medication.

Drug: Ticagrelor
ADP-receptor blocker. Oral formulation. Standard Therapy in Acute Myocardial Infarction. Administered in the ambulance in arm 1 and in the hospital (catheterization laboratory) in arm 2.
Other Names:
  • Brilique
  • Brilinta

Drug: Cangrelor Tetrasodium
Intravenous ADP-receptor blocker. Administered after hospital arrival in the catheterization laboratory.
Other Names:
  • Kengrexal
  • Kengreal




Primary Outcome Measures :
  1. Platelet reactivity 10 minutes PCI after is initiated [ Time Frame: 10 minutes ]
    Platelet reactivity measured in platelet reactivity units (PRU) by the VerifyNow® assay 10 minutes after PCI is initiated.


Secondary Outcome Measures :
  1. Platelet reactivity before and after PCI [ Time Frame: 2 hours ]
    Effect on platelet reactivity, measured by VerifyNow® after sheath insertion, at the end of the PCI procedure (before sheath removal) and two hours after PCI is initiated

  2. Proportion of patients with inappropriate or harmful P2Y12 administration [ Time Frame: 4 hours ]
    This is defined as patients with a diagnosis other than acute myocardial infarction or patients where prehospital ticagrelor administration delays surgery (cardiac or other) due to excess bleeding risk.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients triaged for PPCI due to suspicion of STEMI.
  2. Symptom duration < 12 hours

Exclusion Criteria:

  1. Previous inclusion in the study
  2. Already in treatment with ticagrelor, prasugrel or clopidogrel
  3. Treatment with oral anticoagulants (warfarin, coumarins, rivaroxaban, apixaban, dabigatran)
  4. Adjunctive use of glycoprotein IIb/IIIa inhibitor during PCI
  5. Active bleeding
  6. Known, severe kidney failure (GFR < 30 ml/min) and/or liver disease
  7. Women of child bearing ability who are not using contraceptive medication
  8. Severe mental or psychiatric disease, altered mental state (including unconsciousness) making it impossible to achieve informed consent

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): NCT03182855


Contacts
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Contact: Jacob T Sorensen, MD, PhD +4540143563 jacsoe@rm.dk
Contact: Steen D Kristensen, MD, DMSc +4530922336 steendk@dadlnet.dk

Locations
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Denmark
Aarhus University Hospital Not yet recruiting
Aarhus, Denmark, 8200
Contact: Jacob Thorsted Sorensen, MD, PhD    +4540143563    jacsoe@rm.dk   
Contact: Steen D Kristensen, MD, DMSc    +4530922336    stekrist@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Jacob T Sorensen, MD, PhD Aarhus University Hospital, Department of Cardiology, Skejby
Study Director: Steen D Kristensen, MD, DMSc Aarhus University Hospital, Department of Cardiology, Skejby

Publications of Results:

Other Publications:

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Responsible Party: Jacob Sørensen, Md, PhD, University of Aarhus
ClinicalTrials.gov Identifier: NCT03182855     History of Changes
Other Study ID Numbers: 2016-003721-41
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jacob Sørensen, University of Aarhus:
Acute Coronary Syndrome
STEMI
Platelet reactivity
Anti-thrombotic therapy

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction
Acute Coronary Syndrome
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Cangrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs