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Trial record 1 of 74 for:    EUCLID
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A Study Comparing Cardiovascular Effects of Ticagrelor and Clopidogrel in Patients With Peripheral Artery Disease (EUCLID)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01732822
First Posted: November 26, 2012
Last Update Posted: October 30, 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.
Information provided by (Responsible Party):
AstraZeneca
Results First Submitted: July 13, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Peripheral Artery Disease
Interventions: Drug: Ticagrelor
Drug: Clopidogrel

  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
This study was conducted at 821 centres randomising patients across 28 countries. The first patient was enrolled on 04 December 2012. The last visit of the last patient took place on 26 September 2016. In total, 16237 patients were screened.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screened patients randomised to study drug: 85.5%; n=13885 Patients who were not randomised: 14.5%; n=2352 Patients with inclusion criteria for symptomatic lower extremity PAD failed: n=489 Patients with poor metabolizer status for CYP2C19: n=616 Patients with other reason: n=1374

Reporting Groups
  Description
Ticagrelor 90 mg bd No text entered.
Clopidogrel 75 mg od No text entered.

Participant Flow:   Overall Study
    Ticagrelor 90 mg bd   Clopidogrel 75 mg od
STARTED   6930   6955 
COMPLETED   6807 [1]   6842 [1] 
NOT COMPLETED   123   113 
Withdrawal by Subject                123                113 
[1] Includes patients who did not withdraw informed consent prior to the PACD



  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
Ticagrelor 90mg bd No text entered.
Clopidogrel 75mg od No text entered.
Total Total of all reporting groups

Baseline Measures
   Ticagrelor 90mg bd   Clopidogrel 75mg od   Total 
Overall Participants Analyzed 
[Units: Participants]
 6930   6955   13885 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   66.6  (8.4)   66.5  (8.5)   66.6  (8.4) 
Age, Customized 
[Units: Participants]
     
<65 years   2900   2985   5885 
Between 65 and 75 years   2925   2850   5775 
>75 years   1105   1120   2225 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1908  27.5%      1980  28.5%      3888  28.0% 
Male      5022  72.5%      4975  71.5%      9997  72.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic Or Latino   1046   1067   2113 
Not Hispanic Or Latino   5884   5888   11772 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian Or Alaska Native   63   62   125 
Asian   824   810   1634 
Black Or African American   280   289   569 
Native Hawaiian Or Other Pacific Islander   2   3   5 
Other   110   132   242 
White   5651   5659   11310 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

2.  Secondary:   Composite of CV Death, MI, Ischemic Stroke, and ALI   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

3.  Secondary:   CV Death   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

4.  Secondary:   MI   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

5.  Secondary:   All-cause Mortality   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

6.  Secondary:   Composite of CV Death, MI, and All-cause Stroke (Ischemic or Hemorrhagic)   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

7.  Secondary:   ALI   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

8.  Secondary:   Lower Extremity Revascularization   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

9.  Secondary:   Any Revascularisation (Coronary, Peripheral [Limb, Mesenteric, Renal, Carotid and Other])   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

10.  Other Pre-specified:   Net Clinical Benefit (Composite of CV Death/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

11.  Other Pre-specified:   Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/Fatal Bleeding/Intracranial Bleeding)   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

12.  Other Pre-specified:   Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/Fatal Bleeding/Intracranial Bleeding)   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

13.  Other Pre-specified:   Net Clinical Benefit (Composite of All-cause Mortality/MI/Ischemic Stroke/ALI/Major Amputation/TIMI Major Bleeding)   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

14.  Other Pre-specified:   Non-CV Death   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

15.  Other Pre-specified:   Changes in Fontaine Stage   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

16.  Other Pre-specified:   Changes in Rutherford Classification   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

17.  Other Pre-specified:   Change in ABI/TBI From Baseline   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

18.  Other Pre-specified:   Any Amputation Caused by PAD   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

19.  Other Pre-specified:   Major Amputation Caused by PAD   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

20.  Other Pre-specified:   CV-related Hospitalization   [ Time Frame: From randomization to PACD, an average of 2.5 years ]

21.  Other Pre-specified:   TIMI Major Bleeding Events   [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]

22.  Other Pre-specified:   TIMI Major or Minor Bleeding Events   [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]

23.  Other Pre-specified:   PLATO Major Bleeding Events   [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]

24.  Other Pre-specified:   Premature Permanent Discontinuation of Study Drug Due to Any Bleeding Event   [ Time Frame: From the date of first dose and up to and including 7 days following the date of last dose of study drug ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brilinta Global Clinical Lead
Organization: AstraZeneca R&D
phone: +46 31 776 10 00
e-mail: kontakt@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01732822     History of Changes
Other Study ID Numbers: D5135C00001
2011-004616-36 ( EudraCT Number )
First Submitted: November 20, 2012
First Posted: November 26, 2012
Results First Submitted: July 13, 2017
Results First Posted: October 30, 2017
Last Update Posted: October 30, 2017