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Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01603082
First received: May 18, 2012
Last updated: November 9, 2015
Last verified: November 2015
Results First Received: June 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
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
Participants recruited from 15 actively participating sites in the United States of America, from July 2012 until June 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall, 343 participants were screened; 102 met inclusion/exclusion criteria, 100 were randomized. 96 participants completed treatment and 97 participants completed the study.

Reporting Groups
  Description
Ticagrelor 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Clopidogrel 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)

Participant Flow:   Overall Study
    Ticagrelor   Clopidogrel
STARTED   51 [1]   49 [1] 
COMPLETED   49 [2]   48 [3] 
NOT COMPLETED   2   1 
Adverse Event                0                1 
Withdrawal by Subject                1                0 
Failed inclusion criterion after dosed                1                0 
[1] Randomized
[2] Completed the study.
[3] Completed the study



  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.
Randomized Analysis Set, defined as all participants who signed informed consent, who provided demographic and/or baseline screening assessments, and who were randomized into the study regardless of the participant's randomization and treatment status in the study.

Reporting Groups
  Description
Ticagrelor 180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Clopidogrel 600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
Total Total of all reporting groups

Baseline Measures
   Ticagrelor   Clopidogrel   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   49   100 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   36   30   66 
>=65 years   15   19   34 
Gender 
[Units: Participants]
     
Female   17   13   30 
Male   34   36   70 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   1   0   1 
Asian   1   2   3 
Black or African American   11   11   22 
White   33   33   66 
Missing values   5   3   8 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   5   1   6 
Not Hispanic or Latino   11   14   25 
Not Reported   28   27   55 
Missing values   7   7   14 
Region of Enrollment 
[Units: Participants]
     
United States   51   49   100 


  Outcome Measures
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1.  Primary:   Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™   [ Time Frame: 2 hours after the loading dose ]

2.  Secondary:   Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™   [ Time Frame: 0.5 hours, end of PCI, and 8 hours after the loading dose ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Tomas LG Andersson, MD, PhD
Organization: AstraZeneca
phone: 1-800-236-9393
e-mail: ClinicalTrialTransparency@astrazeneca.com


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01603082     History of Changes
Other Study ID Numbers: D5130L00014
Study First Received: May 18, 2012
Results First Received: June 1, 2015
Last Updated: November 9, 2015
Health Authority: United States: Food and Drug Administration