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Trial record 71 of 507 for:    ASPIRIN AND P2

High Ticagrelor Loading Dose in STEMI

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ClinicalTrials.gov Identifier: NCT01898442
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: Ticagrelor 180mg
Drug: Ticagrelor 270mg
Drug: Ticagrelor 360mg
Enrollment 52
Recruitment Details Between September 2013 and June 2014.
Pre-assignment Details There were a total of 129 STEMI activations; of these, 52 patients provided their written informed consent to participate in the study and were randomized.
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Period Title: Overall Study
Started 17 17 18
Completed 16 15 15
Not Completed 1 2 3
Reason Not Completed
Hemolysis/technical problems             1             2             2
Patient vomited pills             0             0             1
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg Total
Hide Arm/Group Description

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Total of all reporting groups
Overall Number of Baseline Participants 16 15 15 46
Hide Baseline Analysis Population Description
The primary population was used for analysis of baseline characteristics and primary and secondary endpoints. The primary population was defined as patients who received the randomized loading dose of study medication and had at least 75% of valid data, which needed to include the primary endpoint time point.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 15 participants 15 participants 46 participants
60  (8.6) 58  (8.5) 57  (12.1) 58  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 15 participants 46 participants
Female
2
  12.5%
5
  33.3%
7
  46.7%
14
  30.4%
Male
14
  87.5%
10
  66.7%
8
  53.3%
32
  69.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 15 participants 46 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  31.3%
3
  20.0%
4
  26.7%
12
  26.1%
White
11
  68.8%
12
  80.0%
11
  73.3%
34
  73.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Platelet Reactivity by VerifyNow P2Y12
Hide Description The primary end-point of the study was the comparison of the P2Y12 reaction units (PRU) determined by VerifyNow P2Y12 at 1 hour after administration
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description:

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Overall Number of Participants Analyzed 16 15 15
Least Squares Mean (Standard Error)
Unit of Measure: PRU
188  (20) 125  (23) 228  (23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ticagrelor 180mg, Ticagrelor 270mg, Ticagrelor 360mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Platelet Reactivity by VerifyNow P2Y12 at Other Time Points
Time Frame 30 min and 2, 4, 8, 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description:

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Overall Number of Participants Analyzed 16 15 15
Least Squares Mean (Standard Error)
Unit of Measure: PRU
30 min 231  (15) 225  (17) 249  (17)
2 hours 90  (28) 83  (31) 148  (31)
4 hours 75  (19) 46  (22) 69  (22)
8 hours 60  (18) 44  (21) 78  (21)
24 hours 39  (13) 41  (14) 72  (14)
3.Secondary Outcome
Title Platelet Reactivity by Vasodilator-stimulated Phosphoprotein (VASP) at All Time Points
Hide Description Secondary outcomes included the comparison of the platelet reactivity index (PRI) determined by vasodilator-stimulated phosphoprotein (VASP) at 30 min and 1, 2, 4, 8, 24 hours after ticagrelor loading dose administration
Time Frame 30 min and 1, 2, 4, 8, 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description:

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Overall Number of Participants Analyzed 16 15 15
Least Squares Mean (Standard Error)
Unit of Measure: PRI
30 min 76  (6) 81  (6) 78  (6)
1 hour 56  (7) 51  (8) 78  (8)
2 hours 41  (9) 39  (10) 48  (10)
4 hours 35  (6) 30  (7) 21  (7)
8 hours 25  (5) 30  (5) 23  (5)
24 hours 27  (4) 30  (5) 28  (5)
4.Secondary Outcome
Title Pharmacokinetic Profiles of Ticagrelor (Tmax)
Hide Description Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description:

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Overall Number of Participants Analyzed 16 15 15
Geometric Mean (Full Range)
Unit of Measure: hours
3.9
(2 to 24)
5.0
(1 to 24)
7.4
(2 to 24)
5.Secondary Outcome
Title Pharmacokinetic Profiles of Ticagrelor (Cmax)
Hide Description Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description:

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Overall Number of Participants Analyzed 16 15 15
Geometric Mean (Full Range)
Unit of Measure: ng/mL
789
(95 to 3550)
1208
(276 to 2940)
1208
(242 to 4040)
6.Secondary Outcome
Title Pharmacokinetic Profiles of Ticagrelor (AUC0-t)
Hide Description Pharmacokinetic assessments included determination of plasma concentration of ticagrelor. Time for the maximum plasma concentration (Tmax), maximum observed plasma concentration (Cmax) and the area under the plasma concentration vs. time curve from time 0 to the last measurable concentration (AUC0-t) were calculated.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description:

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

Overall Number of Participants Analyzed 16 15 15
Geometric Mean (Full Range)
Unit of Measure: ng*hr/mL
7893
(1270 to 33974)
12379
(2935 to 33105)
12381
(768 to 66201)
Time Frame In-hospital adverse events, including ischemic events, bleeding, bradyarrhythmias, and dyspnea, defined according to previously reported criteria in the PLATO trial, were recorded.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Hide Arm/Group Description

Standard ticagrelor 180mg loading dose

Ticagrelor 180mg: Randomization to standard ticagrelor loading dose

High ticagrelor 270mg loading dose

Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen

High ticagrelor 360mg loading dose

Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen

All-Cause Mortality
Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      1/17 (5.88%)      1/18 (5.56%)    
Vascular disorders       
Ischemic stroke  [1]  0/17 (0.00%)  0 1/17 (5.88%)  1 0/18 (0.00%)  0
Major-life threatening bleed  [2]  0/17 (0.00%)  0 0/17 (0.00%)  0 1/18 (5.56%)  1
Indicates events were collected by systematic assessment
[1]
One patients in the 270mg group developed a peri-PCI ischemic stroke, which was manged according to standard-of-care.
[2]
One patient in the 360mg group experienced a major-life threatening bleed (hypovolemic shock requiring vasopressor and transfusion)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ticagrelor 180mg Ticagrelor 270mg Ticagrelor 360mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/17 (11.76%)      1/17 (5.88%)      0/18 (0.00%)    
Vascular disorders       
Minimal/minor bleeding  [1]  2/17 (11.76%)  2 1/17 (5.88%)  1 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Vascular access-related bleeding
The study was not powered to assess safety or efficacy, which would require larger clinical studies. Although laboratory personnel were blinded to treatment assignment, the study had an open-label design.
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 - Jacksonville
Phone: 9042443933
EMail: dominick.angiolillo@jax.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01898442     History of Changes
Other Study ID Numbers: TicagSTEMI
First Submitted: July 1, 2013
First Posted: July 12, 2013
Results First Submitted: May 26, 2015
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015