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Reversing Ticagrelor's Effects With Fresh Platelets

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ClinicalTrials.gov Identifier: NCT02201394
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Juan J Badimon, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Interventions Drug: Ticagrelor loading dose
Drug: Aspirin loading dose
Drug: Ticagrelor maintenance dose
Drug: Aspirin maintenance dose
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Stable CVD
Hide Arm/Group Description DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
Period Title: Loading Dose
Started 20
Completed 20
Not Completed 0
Period Title: Maintenance Dose
Started 20
Completed 20
Not Completed 0
Arm/Group Title Patients With Stable CVD
Hide Arm/Group Description DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
56.9  (7.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
7
  35.0%
Male
13
  65.0%
Diabetic  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
15
  75.0%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 20 participants
30.7  (4.5)
[1]
Measure Description: Body Mass Index
Hypertension  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
16
  80.0%
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 20 participants
127.2  (17.5)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 20 participants
70.6  (9.0)
Hypercholesterolemia  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
19
  95.0%
Cholesterol level  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 20 participants
158.7  (62.0)
Triglycerides level  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 20 participants
165.4  (91.4)
LDL level   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 20 participants
85.6  (51.7)
[1]
Measure Description: low-density lipoprotein
HDL   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 20 participants
42.5  (12.6)
[1]
Measure Description: high-density lipoprotein
Smoking History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Current
2
  10.0%
Past
8
  40.0%
Never
10
  50.0%
Alcohol Use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Current
9
  45.0%
Past
3
  15.0%
Never
8
  40.0%
1.Primary Outcome
Title P2Y12 Reaction Unit (PRU)
Hide Description Platelet function normalization using different concentrations (0%, 25%, 50%, and 75% supplementations) of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using VerifyNow and expressed as P2Y12 Reaction Unit (PRU). The P2Y12 reaction unit (PRU) is an arbitrary unit of measure that represents the amount of platelet aggregation specific to the P2Y12 receptor.
Time Frame Baseline (pre-treatment), 4, 6, 24 and 48 hours post Loading dose/last Maintenance dose
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with stable CVD
Arm/Group Title Loading Dose Maintenance Dose
Hide Arm/Group Description:
Ticagrelor (180 mg) + ASA (325 mg).
Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: PRU
Baseline 284.1  (42.2) 284.1  (42.2)
Post-dose 4 hours 0% 39.1  (25.9) 37.5  (32.4)
4 hours 25% 69.6  (35.6) 72.2  (38.5)
4 hours 50% 100.3  (49.6) 88.4  (42.9)
4 hours 75% 98.6  (54.4) 85.9  (49.4)
Post-dose 6 hours 0% 25.9  (28.9) 24.0  (30.3)
6 hours 25% 55.3  (50.2) 46.0  (37.3)
6 hours 50% 67.8  (53.8) 55.4  (41.8)
6 hours 75% 71.2  (42.8) 67.7  (45.3)
Post-dose 24 hours 0% 127.6  (58.8) 119.0  (78.0)
24 hours 25% 157.3  (52.5) 147.6  (65.2)
24 hours 50% 165.9  (40.5) 158.0  (43.5)
24 hours 75% 162.5  (29.4) 154.0  (51.0)
Post-dose 48 hours 0% 250.6  (45.8) 214.8  (74.0)
48 hours 25% 249.5  (35.1) 219.7  (52.2)
48 hours 50% 226.2  (51.6) 221.2  (44.2)
48 hours 75% 204.2  (45.9) 203.9  (41.5)
2.Primary Outcome
Title Platelet Aggregation Using Multiplate Analyzer
Hide Description Platelet function normalization using different concentrations of fresh platelet within 48 hours of Ticagrelor Loading dose/last Maintenance dose, assessed using Multiplate Aggregometry (ADPtest), results expressed as Area Under Curve (U), where 1 U = 10 AU * min.
Time Frame Baseline (pre-treatment), 4, 6, 24, and 48 hours post Loading dose/last Maintenance dose
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with stable CVD
Arm/Group Title Loading Dose Maintenance Dose
Hide Arm/Group Description:
Ticagrelor (180 mg) + ASA (325 mg).
Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: 10 AU * min
Baseline (pre-dose 67.0  (14.3) 67.0  (14.3)
Post-dose 4 hours 0% 13.6  (4.6) 15.7  (6.7)
4 hours 25% 18.7  (5.2) 20.9  (6.1)
4 hours 50% 21.4  (7.7) 22.1  (5.9)
4 hours 75% 23.6  (8.4) 24.2  (6.3)
Post-dose 6 hours 0% 12.3  (5.9) 13.4  (6.0)
6 hours 25% 17.3  (6.1) 16.5  (5.5)
6 hours 50% 20.7  (6.5) 18.9  (6.3)
6 hours 75% 22.3  (7.5) 20.4  (6.2)
Post dose 24 hours 0% 24.9  (14.0) 25.6  (15.6)
24 hours 25% 39.7  (18.1) 35.5  (15.1)
24 hours 50% 49.3  (17.9) 43.3  (16.7)
24 hours 75% 52.8  (22.7) 47.5  (18.2)
Post-dose 48 hours 0% 41.3  (17.7) 39.1  (21.3)
48 hours 25% 57.7  (17.6) 56.8  (19.5)
48 hours 50% 68.6  (20.4) 63.8  (19.1)
48 hours 75% 72.8  (18.4) 70.3  (23.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Stable CVD
Hide Arm/Group Description DAPT loading dose (Ticagrelor (180 mg) + ASA (325 mg)); DAPT maintenance therapy (Ticagrelor (90 mg BID) + ASA (81 mg OD), for one week (in same patients)
All-Cause Mortality
Patients With Stable CVD
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Stable CVD
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Stable CVD
Affected / at Risk (%)
Total   0/20 (0.00%) 
Study design is partly in vitro as testing of study aims (reversing effects of antiplatelet therapy by adding fresh platelets in different concentrations and at different times) would be nearly impossible using an in vivo study design.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Juan J. Badimon
Organization: Atherothrombosis Research Unit, Mount Sinai Heart, Icahn School of Medicine at Mount Sinai
Responsible Party: Juan J Badimon, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02201394     History of Changes
Other Study ID Numbers: GCO 13-1802
First Submitted: July 24, 2014
First Posted: July 28, 2014
Results First Submitted: September 26, 2017
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017