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Trial record 54 of 507 for:    ASPIRIN AND P2

Prasugrel/Clopidogrel Maintenance Dose Washout Study

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ClinicalTrials.gov Identifier: NCT01014624
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : September 9, 2011
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: prasugrel
Drug: clopidogrel
Enrollment 56
Recruitment Details Subjects were recruited at 4 sites in the US from 23 February 2010 to 04 May 2010 and 56 subjects were randomized into the study. The study population consisted of male and female aspirin-treated subjects with stable coronary artery disease, 18 to 75 years of age.
Pre-assignment Details Following a 1-day to 14-day Screening Period, eligible subjects were randomized in a 1:1 ratio to either prasugrel or clopidogrel at Visit 2 (the first day of the Active Treatment Period).
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description Prasugrel 10 mg daily Clopidogrel 75 mg daily
Period Title: Overall Study
Started 29 27
Completed 27 26
Not Completed 2 1
Arm/Group Title Prasugrel Clopidogrel Total
Hide Arm/Group Description Prasugrel 10 mg tablet daily Clopidogrel 75 mg tablet daily Total of all reporting groups
Overall Number of Baseline Participants 29 27 56
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 27 participants 56 participants
57.5  (8.45) 62.3  (8.10) 59.80  (8.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Female
4
  13.8%
7
  25.9%
11
  19.6%
Male
25
  86.2%
20
  74.1%
45
  80.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Hispanic or Latino
1
   3.4%
0
   0.0%
1
   1.8%
Not Hispanic or Latino
28
  96.6%
27
 100.0%
55
  98.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
American Indian or Alaska Native
1
   3.4%
0
   0.0%
1
   1.8%
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
5
  17.2%
5
  18.5%
10
  17.9%
White
22
  75.9%
22
  81.5%
44
  78.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   3.4%
0
   0.0%
1
   1.8%
weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 29 participants 27 participants 56 participants
97.3  (15.13) 90.8  (14.41) 94.1  (15.02)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 29 participants 27 participants 56 participants
174.1  (8.20) 173.5  (9.00) 173.8  (8.52)
Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Hispanic or Latino 1 0 1
Non Hispanic or Latino 28 27 55
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 29 participants 27 participants 56 participants
32.0  (4.07) 30.3  (5.34) 31.2  (4.76)
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Never smoked 7 10 17
Currently Smoke 10 6 16
Formerly Smoked 12 11 23
Alcohol Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Never used alcohol 3 5 8
Currently use alcohol 19 18 37
Formerly used alcohol 7 4 11
Diabetes status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 29 participants 27 participants 56 participants
Does not have diabetes 18 16 34
Has diabetes 11 11 22
1.Primary Outcome
Title The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Primary Definition of Return to Baseline
Hide Description On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of subjects.
Time Frame up to 12 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Primary Population (Pop.) using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units.
Arm/Group Title Prasugrel 10 mg Daily Clopidogrel 75 mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: cumulative percentage of subjects
return to baseline PRU by washout day 1 0 30.8
return to baseline PRU by washout day 3 3.6 53.9
return to baseline PRU by washout day 5 37.0 84.6
return to baseline PRU by washout day 6 62.9 96.2
return to baseline PRU by washout day 7 77.8 96.2
return to baseline PRU by washout day 9 100.0 100.0
2.Primary Outcome
Title The Time to Return to Baseline Platelet Function as Assessed by P2Y12 Reaction Units (PRU) Using the Accumetrics VerifyNOW P2Y12 Device Based on the Secondary Definition of Return to Baseline.
Hide Description On the first day of the Washout Period (visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%
Time Frame up to 12 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Primary Pop. using secondary definition of return to baseline. Primary Population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%
Arm/Group Title Prasugrel 10mg Daily Clopidogrel 75mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: cumulative percent returned to baseline
returned to baseline PRU by washout day 1 0.0 30.8
returned to baseline PRU by washout day 3 0.0 53.9
returned to baseline PRU by washout day 5 37.0 80.8
returned to baseline PRU by washout day 6 55.6 88.5
returned to baseline PRU by washout day 7 77.8 96.2
returned to baseline PRU by washout day 9 100.0 100.0
3.Secondary Outcome
Title Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Primary Definition of Return to Baseline Using the Primary Population.
Hide Description On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
Time Frame up to 12 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Primary Population using primary definition of return to baseline. Primary population included subjects entered the Washout Period and had platelet function data at both baseline and Washout Period Day 1. Primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units
Arm/Group Title Prasugrel Clopidogrel
Hide Arm/Group Description:
Prasugrel 10 mg tablet daily
Clopidogrel 75 mg tablet daily
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: day 50%, 75%, 90% returned to baseline
Washout day 50% returned to baseline PRU 6 3
Washout day 75% returned to baseline PRU 7 5
Washout day 90% returned to baseline PRU 9 6
4.Secondary Outcome
Title Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on Secondary Definition of Return to Baseline Using the Primary Population.
Hide Description On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
Time Frame up to 12 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Primary Population using secondary definition of return to baseline. Primary Population included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Secondary definition of return to baseline was (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%
Arm/Group Title Prasugrel 10mg Daily Clopidogrel 75mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: day 50%, 75%, 90% returned to baseline
Washout day 50% returned to baseline PRU 6 3
Washout day 75% returned to baseline PRU 7 5
Washout day 90% returned to baseline PRU 9 7
5.Secondary Outcome
Title Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Primary Definition of Return to Baseline Using the Responder Population.
Hide Description On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/-6 hours) after the last dose of study medication. Following Visit 3, platelet function testing ws performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/Baseline PRU less than or equal to 20%.
Time Frame up to 12 days after last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Responder Pop. using primary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at baseline and Washout Day 1. Responder Pop. was Primary Pop. excluding poor pharmacodynamic responders. Primary definition of R-to-B was (Baseline PRU-PRU) less than or equal to 60 units
Arm/Group Title Prasugrel 10mg Daily Clopidogrel 75mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 15
Measure Type: Number
Unit of Measure: day 50%, 75%, 90% returned to baseline
Washout day 50% returned to baseline PRU 6 5
Washout day 75% returned to baseline PRU 7 5
Washout day 90% returned to baseline PRU 9 6
6.Secondary Outcome
Title Day at Which 50%, 75%, and 90% of Subjects Returned to Baseline Platelet Function Based on the Secondary Definition of Return to Baseline Using the Responder Population.
Hide Description On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to (<=) 20%
Time Frame up to 12 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Responder Pop. using secondary definition of R-to-B. Primary Pop. included subjects entered Washout Period and had platelet function data at both baseline and Washout Period Day 1. Responder Pop. was primary pop. excluding poor pharmacodynamic responders. Secondary definition of R-to-B was (Baseline PRU-PRU)/ (Baseline PRU) <= 20%
Arm/Group Title Prasugrel 10mg Daily Clopidogrel 75mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 15
Measure Type: Number
Unit of Measure: day50%, 75%, 90% returned to baseline
Washout day 50% returned to baseline PRU 6 5
Washout day 75% returned to baseline PRU 7 6
Washout day 90% returned to baseline PRU 9 7
7.Secondary Outcome
Title Percentage of Platelet Inhibition on Washout Day 1
Hide Description On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hour (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the subject met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%
Time Frame Washout Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3).
Arm/Group Title Prasugrel 10mg Daily Clopidogrel 75mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 26
Mean (Standard Deviation)
Unit of Measure: Percentage
72.3  (11.78) 35.4  (23.35)
8.Secondary Outcome
Title Time to Return to Baseline PRU for the Primary Population Using the Primary Definition of Return to Baseline in Relation to the Inhibition of Platelet Aggregation 24 Hours Following the Last Maintenance Dose.
Hide Description Time to return to baseline PRU (<= 60 units of baseline) dependent upon baseline PRU and platelet % inhibition on Washout Period Day 1 but independent of treatment. The following regression model was derived for predicting number of days to R-to-B PRU where PI(1) represents platelet percentage inhibition on Washout Day 1. Number days to R-to-B PRU derived from: Number days to R-to-B PRU=-3.350+0.079*PI(1)+0.014*baseline PRU.
Time Frame up to 12 days after the last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the Primary Population. The Primary Population included subjects who entered the Washout Period and had platelet function testing data at both baseline (Visit 2) and Washout Period Day 1 (Visit 3). The primary definition of return to baseline was (Baseline PRU-PRU) less than or equal to 60 units.
Arm/Group Title Prasugrel 10mg Daily Clopidogrel 75mg Daily
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: days to return to baseline PRU
6.2 3.7
Time Frame Beginning with screening, adverse events (AEs) were assessed at every visit. All AEs occuring after subject signed informed consent and up to 14 days after last dose of study drug were recorded
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prasugrel 10 mg/Daily Clopidogrel 75mg/ Daily
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Prasugrel 10 mg/Daily Clopidogrel 75mg/ Daily
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prasugrel 10 mg/Daily Clopidogrel 75mg/ Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Prasugrel 10 mg/Daily Clopidogrel 75mg/ Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/29 (41.38%)      9/27 (33.33%)    
Ear and labyrinth disorders     
eyelid oedema  1  1/29 (3.45%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Adominal discomfort  1  1/29 (3.45%)  1 0/27 (0.00%)  0
Diarrhoea  1  1/29 (3.45%)  1 2/27 (7.41%)  2
Nausea  1  0/29 (0.00%)  0 1/27 (3.70%)  1
Adominal pain upper  1  0/29 (0.00%)  0 1/27 (3.70%)  1
General disorders     
Pain  1  1/29 (3.45%)  1 0/27 (0.00%)  0
Infections and infestations     
nasopharyngitis  1  0/29 (0.00%)  0 1/27 (3.70%)  1
Upper respiratory tract infection  1  0/29 (0.00%)  0 1/27 (3.70%)  1
viral infection  1  1/29 (3.45%)  1 0/27 (0.00%)  0
Metabolism and nutrition disorders     
diabetes mellitus  1  0/29 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders     
dizziness  1  1/29 (3.45%)  1 0/27 (0.00%)  0
headache  1  1/29 (3.45%)  1 0/27 (0.00%)  0
Psychiatric disorders     
insomnia  1  1/29 (3.45%)  1 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders     
epistaxis  1  2/29 (6.90%)  2 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
ecchymosis  1  0/29 (0.00%)  0 1/27 (3.70%)  1
increased tendency to bruise  1  2/29 (6.90%)  2 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
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
Layout table for Results Point of Contact information
Name/Title: Brian Baker
Organization: Daiichi Sankyo, Inc.
Phone: 973-944-2712
EMail: bbaker@dsi.com
Layout table for additonal information
Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT01014624     History of Changes
Other Study ID Numbers: CS747S-B-U4001
First Submitted: November 16, 2009
First Posted: November 17, 2009
Results First Submitted: May 31, 2011
Results First Posted: September 9, 2011
Last Update Posted: February 13, 2012