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Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function in Humans (HI-TECH) (HI-TECH)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02587260
Recruitment Status : Completed
First Posted : October 27, 2015
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Covance
Information provided by (Responsible Party):
Marco Valgimigli, Erasmus Medical Center

Brief Summary:
The purpose of this randomized, cross-over study, is to ascertain if ticagrelor, but not prasugrel or clopidogrel, is associated to an improved endothelial function as assessed with peripheral arterial tonometry and markers of endothelial function measurement in post-ACS patients.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: Ticagrelor Drug: Prasugrel Drug: Clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Latin square design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hunting for the Off-Target Properties of Ticagrelor on Endothelial Function and Other Circulating Biomarkers in Humans
Actual Study Start Date : December 17, 2015
Actual Primary Completion Date : February 10, 2017
Actual Study Completion Date : February 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sequence I
Ticagrelor in the period I Prasugrel in the period II Clopidogrel in the period III
Drug: Ticagrelor
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Brilique

Drug: Prasugrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Efient

Drug: Clopidogrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Plavix

Active Comparator: Sequence II
Ticagrelor in the period I Clopidogrel in the period II Prasugrel in the period III
Drug: Ticagrelor
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Brilique

Drug: Prasugrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Efient

Drug: Clopidogrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Plavix

Active Comparator: Sequence III
Prasugrel in the period I Ticagrelor in the period II Clopidogrel in the period III
Drug: Ticagrelor
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Brilique

Drug: Prasugrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Efient

Drug: Clopidogrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Plavix

Active Comparator: Sequence IV
Prasugrel in the period I Clopidogrel in the period II Ticagrelor in the period III
Drug: Ticagrelor
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Brilique

Drug: Prasugrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Efient

Drug: Clopidogrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Plavix

Active Comparator: Sequence V
Clopidogrel in the period I Ticagrelor in the period II Prasugrel in the period III
Drug: Ticagrelor
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Brilique

Drug: Prasugrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Efient

Drug: Clopidogrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Plavix

Active Comparator: Sequence VI
Clopidogrel in the period I Prasugrel in the period II Ticagrelor in the period III
Drug: Ticagrelor
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Brilique

Drug: Prasugrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Efient

Drug: Clopidogrel
Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
Other Name: Plavix




Primary Outcome Measures :
  1. Improvement of endothelial function at steady state [ Time Frame: After 30 days of therapy with assigned P2Y12-inhibitor ]
    Evaluation if ticagrelor, at steady state (i.e. after 30 day therapy), will be associated to an improved endothelial function as compared to clopidogrel or prasugrel when assessed with endopath system 1-2 hour(s) after maintenance drug intake.


Secondary Outcome Measures :
  1. Improvement of endothelial function, both acutely and at steady state [ Time Frame: One or 2 hour(s) after P2Y12-inhibitor loading dose administration and before and 1 or 2 hour(s) after maintenance dose administration ]
    To assess if treatment with ticagrelor, both acutely and at steady state is associated to an improved endothelial function phenotype as compared to clopidogrel or prasugrel. The assessment is made with measurement of blood markers of endothelial function.



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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:

  • Patients older than 18 years.
  • Patients who experienced an Acute Coronary Syndrome (including STEMI or NSTEMI) at least 30 days before.
  • Patients on ongoing treatment for at least 30 days with dual anti-platelet therapy consisting of aspirin, at doses of 75-160 mg daily and one commercially available P2Y12 oral inhibitor , including ticagrelor, clopidogrel or prasugrel.
  • Patients who remained free from bleeding (defined as BARC type 2 or greater) or ischemic recurrences.
  • Signed informed consent All inclusion criteria are required.

Exclusion Criteria:

  • Administration of fibrinolytics or glycoprotein IIb/IIIa inhibitors in the previous 30 days.
  • Major surgery within 30 days or any planned surgical or percutaneous intervention.
  • Active bleeding or previous clinical relevant bleeding or stroke in the last 6 months.
  • Previous transient ischemic attack or intracranial bleeding.
  • Thrombocytopenia.
  • Oral anticoagulant therapy.
  • Vasculitis or any know immunological disorder.
  • Severe hepatic failure.
  • Uncontrolled hypertension (systolic or diastolic arterial pressure >180 mmHg or 120, respectively, despite medical therapy).
  • Known intolerance to aspirin or to clopidogrel or prasugrel or ticagrelor.
  • Limited life expectancy, e.g. neoplasms, others.
  • Inability to obtain informed consent.
  • Pregnancy.

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): NCT02587260


Locations
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Italy
Policlinico San Matteo
Pavia, Italy, 27100
Netherlands
VU Medical Center
Amsterdam, Netherlands, 1081 HZ
Erasmus MC
Rotterdam, Netherlands, 3015 CE
Spain
Hospital Clinic
Barcelona, Spain, 08036
Switzerland
Inselspitäl University Medical Center
Bern, Switzerland, 3010
Sponsors and Collaborators
Erasmus Medical Center
Covance
Investigators
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Principal Investigator: Marco Valgimigli, MD, PhD Erasmus MC, Rotterdam, the Netherlands
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Marco Valgimigli, Coordinating Investigator/Project Leader, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02587260    
Other Study ID Numbers: NL51124.078.14
2014-004189-64 ( EudraCT Number )
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Marco Valgimigli, Erasmus Medical Center:
P2Y12 inhibitors
Acute Coronary Syndrome (ACS)
Endothelial function
Adenosine measurement in human subject
Endopath
Additional relevant MeSH terms:
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Cardiovascular Diseases
Clopidogrel
Ticagrelor
Prasugrel Hydrochloride
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