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Trial record 3 of 27 for:    cangrelor

Cangrelor Following Ticagrelor Loading vs Ticagrelor Loading Alone in STEMI

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ClinicalTrials.gov Identifier: NCT02943369
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
AHEPA University Hospital
University Hospital, Alexandroupolis
Information provided by (Responsible Party):
Dimitrios Alexopoulos, Attikon Hospital

Brief Summary:
Platelets and thrombus formation play a key role in the pathogenesis of acute coronary artery occlusion and subsequent myocardial infarction. Apart from mechanically opening the occluded artery with angioplasty, adjunctive antiplatelet treatment is of utmost importance. However, orally administered antiplatelet agents exhibit a delay in their onset of action in the setting of acute myocardial infarction and angioplasty is mostly performed without adequate platelet inhibition. Cangrelor is an intravenous antiplatelet agent which can provide almost immediate strong platelet inhibition. The investigators aim to compare a strategy of cangrelor administered on top of ticagrelor-an oral antiplatelet agent- vs ticagrelor alone, on their efficacy to inhibit platelet function in the early hours of an acute myocardial infarction.

Condition or disease Intervention/treatment Phase
STEMI Drug: Ticagrelor 180 mg loading dose Drug: Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cangrelor Administration Following Ticagrelor Loading vs Ticagrelor Loading Alone in ST Segment Elevation Myocardial Infarction Patients: A Randomized, Pharmacodynamic Study
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : November 26, 2017
Actual Study Completion Date : December 26, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Cangrelor
Ticagrelor will be followed by Cangrelor
Drug: Ticagrelor 180 mg loading dose
Ticagrelor 180 mg
Other Name: Ticagrelor 180 mg

Drug: Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min
Intravenous Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min for 2 hours
Other Name: Cangrelor bolus and infusion

Active Comparator: Ticagrelor
Ticagrelor only
Drug: Ticagrelor 180 mg loading dose
Ticagrelor 180 mg
Other Name: Ticagrelor 180 mg




Primary Outcome Measures :
  1. Platelet reactivity between the 2 arms [ Time Frame: 15 min ]
    Platelet reactivity in P2Y12 reaction units by VerifyNow assay


Secondary Outcome Measures :
  1. Platelet reactivity between the 2 arms [ Time Frame: 1 hour ]
    Platelet reactivity in P2Y12 reaction units by VerifyNow assay

  2. Platelet reactivity between the 2 arms [ Time Frame: 2 hours ]
    Platelet reactivity in P2Y12 reaction units by VerifyNow assay

  3. Platelet reactivity between the 2 arms [ Time Frame: 4 hours ]
    Platelet reactivity in P2Y12 reaction units by VerifyNow assay

  4. High on treatment platelet reactivity rate [ Time Frame: 15 min ]
    High on treatment platelet reactivity rate

  5. High on treatment platelet reactivity rate [ Time Frame: 1 hour ]
    High on treatment platelet reactivity rate

  6. High on treatment platelet reactivity rate [ Time Frame: 2 hours ]
    High on treatment platelet reactivity rate

  7. High on treatment platelet reactivity rate [ Time Frame: 4 hours ]
    High on treatment platelet reactivity rate


Other Outcome Measures:
  1. major adverse cardiac events (death, myocardial infarction, stroke, ischemia driven revascularization) [ Time Frame: 30 days ]
  2. Bleeding events (BARC classification) [ Time Frame: 30 days ]
  3. Other adverse events [ Time Frame: 30 days ]


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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive P2Y12 inhibitor-naive STEMI patients with pain onset<12 hours admitted for primary PCI.

Exclusion Criteria:

  • a history of stroke/transient ischemic attack
  • bleeding diathesis
  • chronic oral anticoagulation treatment
  • contraindications to anti platelet therapy
  • PCI or coronary artery bypass grafting <3 months
  • platelet count <100 000/μL
  • hematocrit <30%
  • creatinine clearance <30 mL/min
  • severe hepatic dysfunction
  • use of strong CYP3A inhibitors or inducers
  • increased risk of bradycardia
  • severe chronic obstructive pulmonary disease
  • periprocedural IIb/IIIa inhibitor administration.

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): NCT02943369


Locations
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Greece
Attikon University Hospital
Athens, Attika, Greece, 12462
Sponsors and Collaborators
Attikon Hospital
AHEPA University Hospital
University Hospital, Alexandroupolis
Investigators
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Principal Investigator: Dimitrios Alexopoulos, MD Attikon University Hospital

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Responsible Party: Dimitrios Alexopoulos, Professor of Cardiology, National and Capodestrian University of Athens, Attikon Hospital
ClinicalTrials.gov Identifier: NCT02943369     History of Changes
Other Study ID Numbers: IIS13616
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: December 27, 2017
Last Verified: December 2017
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 Dimitrios Alexopoulos, Attikon Hospital:
cangrelor
ticagrelor
P2Y12 receptor antagonist
acute myocardial infarction
Additional relevant MeSH terms:
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Cangrelor
ST Elevation Myocardial Infarction
Myocardial Infarction
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