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Trial record 24 of 466 for:    pharmacogenomics

Pharmacogenomics of Anti-platelet Intervention-2 (PAPI-2) Study (PAPI-2)

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ClinicalTrials.gov Identifier: NCT01452152
Recruitment Status : Terminated (Terminated by study sponsor.)
First Posted : October 14, 2011
Results First Posted : June 28, 2016
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alan Shuldiner, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cardiovascular Diseases
Acute Coronary Syndrome
Interventions: Drug: clopidogrel
Drug: prasugrel

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Genotype-directed, Clopidogrel

Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.

clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year

Genotype-directed, Prasugrel

Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.

prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year

Standard of Care Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.

Participant Flow:   Overall Study
    Genotype-directed, Clopidogrel   Genotype-directed, Prasugrel   Standard of Care
STARTED   5   0   4 
COMPLETED   0   0   0 
NOT COMPLETED   5   0   4 
Study termination by sponsor                5                0                4 



  Baseline Characteristics

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
Genotype-directed, Clopidogrel

Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.

clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year

Genotype-directed, Prasugrel

Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.

prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year

Standard of Care Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
Total Total of all reporting groups

Baseline Measures
   Genotype-directed, Clopidogrel   Genotype-directed, Prasugrel   Standard of Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   0   4   9 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%         0   0.0%      0   0.0% 
Between 18 and 65 years      3  60.0%         3  75.0%      6  66.7% 
>=65 years      2  40.0%         1  25.0%      3  33.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      1  20.0%         2  50.0%      3  33.3% 
Male      4  80.0%         2  50.0%      6  66.7% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%         1  25.0%      1  11.1% 
Not Hispanic or Latino      5 100.0%         3  75.0%      8  88.9% 
Unknown or Not Reported      0   0.0%         0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%         0   0.0%      0   0.0% 
Asian      0   0.0%         0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%         0   0.0%      0   0.0% 
Black or African American      0   0.0%         1  25.0%      1  11.1% 
White      5 100.0%         2  50.0%      7  77.8% 
More than one race      0   0.0%         0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%         1  25.0%      1  11.1% 


  Outcome Measures

1.  Primary:   Occurrence of Post-randomization Cardiovascular Events   [ Time Frame: One year ]

2.  Secondary:   Occurrence of Bleeding Events   [ Time Frame: One year ]

3.  Secondary:   Post-treatment Platelet Aggregation   [ Time Frame: 10 days ]

4.  Secondary:   Health Care Resource Utilization and Cost-effectiveness   [ Time Frame: One year ]

5.  Secondary:   Occurrence of Adverse Events   [ Time Frame: One year ]

6.  Secondary:   Composite of All-cause Death, Myocardial Infarction (MI), Stroke and Repeat Revascularization   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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 terminated early by the sponsor due to low enrollment.


  More Information

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: Dr. Alan R. Shuldiner
Organization: University of Maryland School of Medicine
phone: 410-706-1623
e-mail: ashuldin@medicine.umaryland.edu


Publications:

Responsible Party: Alan Shuldiner, University of Maryland
ClinicalTrials.gov Identifier: NCT01452152     History of Changes
Other Study ID Numbers: HP-00047385
9U01HL105198-06 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2011
First Posted: October 14, 2011
Results First Submitted: February 18, 2016
Results First Posted: June 28, 2016
Last Update Posted: March 5, 2018