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Ticagrelor Versus Clopidogrel in Type 2 Diabetic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823510
First Posted: April 4, 2013
Last Update Posted: September 1, 2017
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.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Juan J Badimon, Icahn School of Medicine at Mount Sinai
Results First Submitted: June 19, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Type-2 Diabetes Mellitus
Coronary Artery Disease
Interventions: Drug: Ticagrelor + Aspirin
Drug: Clopidogrel + Aspirin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tica-Clop Participants received Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days).
Clop-Tica Participants received Clopidogrel plus ASA (loading-dose plus daily-dose for 5-7 days), followed by Washout (14 days), and then Ticagrelor plus ASA (loading-dose plus daily-dose for 5-7 days).

Participant Flow for 3 periods

Period 1:   Days 1-7
    Tica-Clop   Clop-Tica
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 

Period 2:   Days 8-21
    Tica-Clop   Clop-Tica
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 

Period 3:   Days 22-28
    Tica-Clop   Clop-Tica
STARTED   10   10 
COMPLETED   10   10 
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
Type 2 Diabetic Patients All participants receive both Ticagrelor and Clopidogrel (each with aspirin) in a cross-over design. Treatment sequence (Tica-Clop OR Clop-Tica) was randomly assigned and with a 2-week washout period in between (i.e., "Tica/Clop (5-7 days)", "Washout (14 days)", and "Clop/Tica (5-7 days)").

Baseline Measures
   Type 2 Diabetic Patients 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.2  (8.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  40.0% 
Male      12  60.0% 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.9  (4.5) 
Diabetes, type-2 
[Units: Participants]
Count of Participants
 20 
Hypertension 
[Units: Participants]
Count of Participants
 17 
Hypercholesterolemia 
[Units: Participants]
Count of Participants
 19 
Smoking 
[Units: Participants]
Count of Participants
 3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Thrombus Formation   [ Time Frame: up to 7 days ]

2.  Secondary:   Platelet Reactivity   [ Time Frame: up to 7 days ]

3.  Secondary:   P2Y12 Reaction Unit (PRU)   [ Time Frame: up to 7 days ]

4.  Secondary:   Platelet Reactivity Index (PRI)   [ Time Frame: up to 7 days ]


  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 Badimon
Organization: Icahn School of Medicine at Mount Sinai
phone: 212-241-8484
e-mail: juan.badimon@mssm.edu



Responsible Party: Juan J Badimon, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01823510     History of Changes
Other Study ID Numbers: GCO 13-0208
First Submitted: March 29, 2013
First Posted: April 4, 2013
Results First Submitted: June 19, 2017
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017