High Ticagrelor Loading Dose in STEMI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01898442
First received: July 1, 2013
Last updated: May 26, 2015
Last verified: June 2014
Results First Received: May 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Drug: Ticagrelor 180mg
Drug: Ticagrelor 270mg
Drug: Ticagrelor 360mg

  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
Between September 2013 and June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were a total of 129 STEMI activations; of these, 52 patients provided their written informed consent to participate in the study and were randomized.

Reporting Groups
  Description
Ticagrelor 180mg

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

Ticagrelor 270mg

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

Ticagrelor 360mg

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen


Participant Flow:   Overall Study
    Ticagrelor 180mg     Ticagrelor 270mg     Ticagrelor 360mg  
STARTED     17     17     18  
COMPLETED     16     15     15  
NOT COMPLETED     1     2     3  
Hemolysis/technical problems                 1                 2                 2  
Patient vomited pills                 0                 0                 1  



  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.
The primary population was used for analysis of baseline characteristics and primary and secondary endpoints. The primary population was defined as patients who received the randomized loading dose of study medication and had at least 75% of valid data, which needed to include the primary endpoint time point.

Reporting Groups
  Description
Ticagrelor 180mg

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

Ticagrelor 270mg

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

Ticagrelor 360mg

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Total Total of all reporting groups

Baseline Measures
    Ticagrelor 180mg     Ticagrelor 270mg     Ticagrelor 360mg     Total  
Number of Participants  
[units: participants]
  16     15     15     46  
Age  
[units: years]
Mean (Standard Deviation)
  60  (8.6)     58  (8.5)     57  (12.1)     58  (9.5)  
Gender  
[units: participants]
       
Female     2     5     7     14  
Male     14     10     8     32  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     5     3     4     12  
White     11     12     11     34  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  



  Outcome Measures
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1.  Primary:   Platelet Reactivity by VerifyNow P2Y12   [ Time Frame: 1 hour ]

2.  Secondary:   Platelet Reactivity by VerifyNow P2Y12 at Other Time Points   [ Time Frame: 30 min and 2, 4, 8, 24 hours ]

3.  Secondary:   Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points   [ Time Frame: 30 min and 1, 2, 4, 8, 24 hours ]

4.  Secondary:   Pharmacokinetic Profiles of Ticagrelor (Tmax)   [ Time Frame: 24 hours ]

5.  Secondary:   Pharmacokinetic Profiles of Ticagrelor (Cmax)   [ Time Frame: 24 hours ]

6.  Secondary:   Pharmacokinetic Profiles of Ticagrelor (AUC0-t)   [ Time Frame: 24 hours ]


  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
The study was not powered to assess safety or efficacy, which would require larger clinical studies. Although laboratory personnel were blinded to treatment assignment, the study had an open-label design.


  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: Dominick J. Angiolillo, MD, PhD
Organization: University of Florida - Jacksonville
phone: 9042443933
e-mail: dominick.angiolillo@jax.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01898442     History of Changes
Other Study ID Numbers: TicagSTEMI
Study First Received: July 1, 2013
Results First Received: May 26, 2015
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board