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Trial record 85 of 507 for:    ASPIRIN AND P2

Pharmacological Effects of Crushing Prasugrel in STEMI Patients

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ClinicalTrials.gov Identifier: NCT02212028
Recruitment Status : Completed
First Posted : August 8, 2014
Results First Posted : December 28, 2016
Last Update Posted : December 28, 2016
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Drug: prasugrel
Enrollment 52
Recruitment Details Between October 15, 2014, and August 12, 2015, there were a total of 123 patients presenting with a STEMI at the University of Florida Health-Jacksonville, that were screened.
Pre-assignment Details 45 patients did not meet study entry criteria, while 78 provided their written informed consent to participate in the study and, of these, 52 were randomized. the remaining subjects were not randomized because of exclusion criteria emerged after consenting.
Arm/Group Title Prasugrel Crush Prasugrel Tablets
Hide Arm/Group Description Prasugrel 60mg loading dose as crushed tablets Prasugrel 60 mg loading dose whole tablets
Period Title: Overall Study
Started 26 26
Completed 26 26
Not Completed 0 0
Arm/Group Title Prasugrel Crush Prasugrel Tablets Total
Hide Arm/Group Description Prasugrel 60mg loading dose as crushed tablets Prasugrel 60 mg loading dose whole tablets Total of all reporting groups
Overall Number of Baseline Participants 26 24 50
Hide Baseline Analysis Population Description
Two patients in the whole tablets arm were excluded from the analysis because of missing data for the primary end point.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 24 participants 50 participants
57  (9) 58  (10) 58  (10)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 participants
Female
7
  26.9%
6
  25.0%
13
  26.0%
Male
19
  73.1%
18
  75.0%
37
  74.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 24 participants 50 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
7
  26.9%
6
  25.0%
13
  26.0%
White
19
  73.1%
18
  75.0%
37
  74.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title P2Y12 Reaction Units (PRU)
Hide Description The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Time Frame 2 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.
Arm/Group Title Prasugrel Crush Prasugrel Tablets
Hide Arm/Group Description:
Prasugrel 60mg loading dose as crushed tablets
Prasugrel 60 mg loading dose whole tablets
Overall Number of Participants Analyzed 26 24
Least Squares Mean (95% Confidence Interval)
Unit of Measure: PRU
95
(55 to 135)
164
(122 to 206)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel Crush
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 68
Confidence Interval (2-Sided) 95%
10 to 126
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Platelet Reactivity Index (PRI)
Hide Description The secondary end-point of the study is the comparison in platelet reactivity expressed as PRI determined by whole blood vasodilator-stimulated phosphoprotein (VASP) between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Time Frame 2 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population was defined as patients who received the randomized treatment and had a valid primary end point value (PRU at 2 hours) and was considered for analysis of all endpoints.
Arm/Group Title Prasugrel Crush Prasugrel Tablets
Hide Arm/Group Description:
Prasugrel 60mg loading dose as crushed tablets
Prasugrel 60 mg loading dose whole tablets
Overall Number of Participants Analyzed 26 24
Least Squares Mean (95% Confidence Interval)
Unit of Measure: PRI
33
(20 to 46)
61
(47 to 75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Prasugrel Crush, Prasugrel Tablets
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 3 days
Adverse Event Reporting Description In-hospital adverse events, including ischemic and bleeding complications were recorded.
 
Arm/Group Title Prasugrel Crush Prasugrel Tablets
Hide Arm/Group Description Prasugrel 60mg loading dose as crushed tablets Prasugrel 60 mg loading dose whole tablets
All-Cause Mortality
Prasugrel Crush Prasugrel Tablets
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Prasugrel Crush Prasugrel Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prasugrel Crush Prasugrel Tablets
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/26 (3.85%)      0/26 (0.00%)    
Renal and urinary disorders     
Minor bleeding * 1 [1]  1/26 (3.85%)  1 0/26 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
There was only 1 minor bleeding event (hematuria) in the crushed prasugrel arm, which did not required drug discontinuation.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dominick J. Angiolillo, MD, PhD
Organization: University of Florida College of Medicine-Jacksonville
Phone: +1-904-244-3933
EMail: dominick.angiolillo@jax.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02212028     History of Changes
Other Study ID Numbers: Prasugrel-CRUSH
First Submitted: August 6, 2014
First Posted: August 8, 2014
Results First Submitted: November 1, 2016
Results First Posted: December 28, 2016
Last Update Posted: December 28, 2016