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Trial record 13 of 27 for:    cangrelor

In Vitro Pharmacodynamic Effects of Cangrelor in Ticagrelor Treated Patients

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ClinicalTrials.gov Identifier: NCT02081443
Recruitment Status : Completed
First Posted : March 7, 2014
Results First Posted : March 3, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
The Medicines Company
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: Other
Condition Coronary Artery Disease
Interventions Drug: Ticagrelor 180mg
Drug: Ticagrelor 90mg
Enrollment 60
Recruitment Details Patients were recruited from October 2014 to October 2015. Patients were screened and recruited in the Cardiology clinics of the Division of Cardiology of University of Florida Jacksonville.
Pre-assignment Details 64 patients were consented for the study. Of these, 3 withdrew from the study before being randomized, 1 had an exclusion criteria. A total of 60 patients were randomized to receive study medications.
Arm/Group Title Ticagrelor 180mg Ticagrelor 90mg
Hide Arm/Group Description The proposed study have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays was done following in vitro incubation with and without 500 nM cangrelor. The proposed study has a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays were done following in vitro incubation with and without 500 nM cangrelor.
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Ticagrelor 180mg Ticagrelor 90mg Total
Hide Arm/Group Description The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor. The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
58  (9) 57  (8) 58  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
11
  36.7%
9
  30.0%
20
  33.3%
Male
19
  63.3%
21
  70.0%
40
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 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
9
  30.0%
6
  20.0%
15
  25.0%
White
21
  70.0%
24
  80.0%
45
  75.0%
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 Platelet Reactivity Index (PRI) Determined by Whole Blood Vasodilator-stimulated Phosphoprotein (VASP)
Hide Description PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 90mg
Hide Arm/Group Description:
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: %PRI
Without cangrelor 30  (3.6) 30  (4)
With cangrelor 18  (1.7) 17  (1.8)
2.Secondary Outcome
Title PRI Measured by VASP
Hide Description PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 90mg
Hide Arm/Group Description:
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: %PRI
Without cangrelor 20  (2.4) 29  (3.4)
With cangrelor 12  (1.6) 16  (1.5)
3.Secondary Outcome
Title PRI Measured by VASP
Hide Description PRI determined by VASP between before and after incubation with 500 nM Cangrelor in each arm of treatment
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ticagrelor 180mg Ticagrelor 90mg
Hide Arm/Group Description:
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
Overall Number of Participants Analyzed 30 30
Mean (Standard Error)
Unit of Measure: %PRI
Without cangrelor 22  (2.4) 22  (2)
With cangrelor 14  (1.2) 17  (1.9)
Time Frame 1 day
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ticagrelor 180mg Ticagrelor 90mg
Hide Arm/Group Description The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor. The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
All-Cause Mortality
Ticagrelor 180mg Ticagrelor 90mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ticagrelor 180mg Ticagrelor 90mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
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 90mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      0/30 (0.00%)    
General disorders     
Dehydration * 1 [1]  1/30 (3.33%)  1 0/30 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
Not study related
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: NCT02081443     History of Changes
Other Study ID Numbers: CIT
First Submitted: March 5, 2014
First Posted: March 7, 2014
Results First Submitted: January 12, 2017
Results First Posted: March 3, 2017
Last Update Posted: April 4, 2017