Antithrombotic Effects of Ticagrelor Versus Clopidogrel

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Juan J Badimon, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT01642238
First received: July 13, 2012
Last updated: June 1, 2016
Last verified: June 2016
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Interventions: Drug: Ticagrelor + ASA + Bivalirudin
Drug: Clopidogrel + ASA + Bivalirudin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
15 healthy volunteers recruited between July 2012 and March 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ticagrelor, Then Clopidogrel Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
Clopidogrel, Then Ticagrelor Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.

Participant Flow for 3 periods

Period 1:   First Intervention (1 Day)
    Ticagrelor, Then Clopidogrel     Clopidogrel, Then Ticagrelor  
STARTED     7     8  
COMPLETED     7     8  
NOT COMPLETED     0     0  

Period 2:   Washout (1-2 Weeks)
    Ticagrelor, Then Clopidogrel     Clopidogrel, Then Ticagrelor  
STARTED     7     8  
COMPLETED     7     8  
NOT COMPLETED     0     0  

Period 3:   Second Intervention (1 Day)
    Ticagrelor, Then Clopidogrel     Clopidogrel, Then Ticagrelor  
STARTED     7     8  
COMPLETED     7     8  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Antithrombotic Effects Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.

Baseline Measures
    Antithrombotic Effects  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Mean (Full Range)
  31.2  
  (26.8 to 35.6)  
Gender  
[units: participants]
 
Female     6  
Male     9  
Body mass index  
[units: kg/m^2]
Mean (Full Range)
  27.0  
  (24.9 to 29.1)  



  Outcome Measures
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1.  Primary:   Platelet-thrombus Formation in an ex Vivo Model of Thrombosis   [ Time Frame: Pre-treatment baseline and 1 hour ]

2.  Primary:   Platelet-thrombus Formation in an ex Vivo Model of Thrombosis   [ Time Frame: Pre-treatment baseline and 24 hrs post treatment ]

3.  Secondary:   Platelet Reactivity   [ Time Frame: Pre-treatment baseline ]

4.  Secondary:   Platelet Reactivity   [ Time Frame: 1 hr post-treatment ]

5.  Secondary:   Platelet Reactivity   [ Time Frame: 24-hours post-treatment ]

6.  Secondary:   Blood Thrombogenicity   [ Time Frame: Pre-treatment baseline ]

7.  Secondary:   Blood Thrombogenicity   [ Time Frame: 1 hr post-treatment ]

8.  Secondary:   Blood Thrombogenicity   [ Time Frame: 24-hours post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Juan J. Badimon
Organization: Icahn School of Medicine at Mount Sinai
phone: (212) 241-8484
e-mail: Juan.Badimon@mssm.edu


Publications of Results:

Responsible Party: Juan J Badimon, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01642238     History of Changes
Other Study ID Numbers: GCO 12-0732
ISSBRIL0067
Study First Received: July 13, 2012
Results First Received: August 14, 2014
Last Updated: June 1, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board