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Different LD of Ticagrelor for Antiplatelet Effect in Patients With Non-ST-segment Elevation ACS Undergoing PCI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01962428
First received: October 10, 2013
Last updated: September 21, 2016
Last verified: December 2015
Results First Received: September 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non ST Segment Elevation Acute Coronary Syndrome
Intervention: Drug: ticagrelor

  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
A total of 278 patients were recruited at 8 centers in Beijing and allocated into two groups using block randomization: a high LD group (360 mg) and a conventional LD group (180 mg).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients excluded(n=564)

Reporting Groups
  Description
High Loading Dose of Ticagrelor

Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Conventional Loading Dose of Ticagrelor

Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.


Participant Flow:   Overall Study
    High Loading Dose of Ticagrelor   Conventional Loading Dose of Ticagrelor
STARTED   139   139 
COMPLETED   129   133 
NOT COMPLETED   10   6 



  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
High Loading Dose of Ticagrelor

Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Conventional Loading Dose of Ticagrelor

Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.

ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.

Total Total of all reporting groups

Baseline Measures
   High Loading Dose of Ticagrelor   Conventional Loading Dose of Ticagrelor   Total 
Overall Participants Analyzed 
[Units: Participants]
 129   133   262 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   75   80   155 
>=65 years   54   53   107 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.7  (9.47)   58.8  (10.26)   59.2  (9.46) 
Gender 
[Units: Participants]
     
Female   40   45   85 
Male   89   88   177 
Region of Enrollment 
[Units: Participants]
     
China   129   133   262 


  Outcome Measures

1.  Primary:   Platelet Reactivity Index(PRI) Measured by VASP-P   [ Time Frame: 2 hours after the loading dose of ticagrelor ]

2.  Secondary:   Platelet Reactivity Index (PRI) Measured by VASP-P   [ Time Frame: 0.5hour,1hour,8hours,24hours after the loading dose of ticagrelor ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Bleeding Events   [ Time Frame: follow-up for 28 days after the loading dose of ticagrelor ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: huiliang Liu
Organization: General Hospital of Chinese People’s Armed Police Forces
phone: +8601057976707
e-mail: lhl518@vip.sina.com



Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01962428     History of Changes
Other Study ID Numbers: ISSBRIL0214
Study First Received: October 10, 2013
Results First Received: September 21, 2016
Last Updated: September 21, 2016
Health Authority: China: Food and Drug Administration