The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
123
Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)
Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)
Oral, 75 mg to 100 mg once daily. Aspirin obtained locally by the investigator, according to local practice. The dose remained constant throughout the study.
Research Site
Baton Rouge, Louisiana, United States
Research Site
Baltimore, Maryland, United States
Research Site
Towson, Maryland, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Rapid City, South Dakota, United States
Research Site
Houston, Texas, United States
Research Site
Sheffield, United Kingdom
Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: At 2 hours after first dose of study drug
Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
IPA(%)=(PAb-PAt)/PAb\*100.The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition. The unit for the slope of IPA curve is percent/hour.
Time frame: 4 to 72 Hours after last dose of study drug
Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 0.5 hours after first dose
Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 1 hour after first dose
Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 4 hours after first dose
Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 8 hours after first dose
Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 24 hours after first dose
Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 0 hour before last dose
Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 2 hours after last dose
Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 4 hours after last dose
Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 8 hours after last dose
Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 24 hours after last dose
Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 48 hours after last dose
Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 72 hours after last dose
Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 120 hours - Day 5 after last dose
Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference of baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 168 hours - Day 7 after last dose
Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
IPA(%)=(PAb-PAt)/PAb\*100. The unit % is the percentage of difference for baseline versus post baseline value relative to baseline value of platelet aggregation. PA (platelet aggregation) is measured by LTA (Light Transmittance Aggregometry). PAb is the response at baseline (last measurement before study drug) and PAt is a response at post-treatment. IPA=0% means no PA inhibition and 100% means 100% PA inhibition.
Time frame: 240 hours - Day 10 after last dose
Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is measured by Spirometry, the unit is Liter.
Time frame: Baseline
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
FEV1 is measured by Spirometry, the unit is Liter.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
FVC is measured by Spirometry, the unit is Liter.
Time frame: Baseline
Cardiopulmonary Parameters at Post 6-week Treatment: FVC
FVC is measured by Spirometry, the unit is Liter.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time frame: Baseline
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
FRC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: FRC
FRC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
TLC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: TLC
TLC is measured by Body Box Plethysmography, the unit is Liter.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
RV is measured by Body Box Plethysmography, the unit is Liter.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: RV
RV is measured by Body Box Plethysmography, the unit is Liter.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: VE
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: RR
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: VT
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: EF
EF is measured by Echocardiogram, the unit is Percent. The ejection fraction is defined by: (LV diastolic volume - LV systolic volume)/LV diastolic volume. The unit % is the percentage change of left ventricular diastolic versus systolic volume relative to the diastolic volume. LV is the left ventricle.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time frame: 6-week post treatment
Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Time frame: Baseline
Cardiopulmonary Parameters Post 6-week Treatment: SpO2
SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Time frame: 6-week post treatment
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