A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin
- Conditions
- Coronary Artery Disease
- Interventions
- Registration Number
- NCT00528411
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- Documented stable Coronary Artery Disease (stable angina, previous MI history, previous history of revascularization);
- Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception
- History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or Coronary Artery Bypass Graft (CABG))
- History of liver or kidney disease
- Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma
- History of intolerance or allergy to Aspirin or clopidogrel
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Clopidogrel (over encapsulated) capsule Aspirin + clopidogrel 2 Aspirin Tablets Aspirin + clopidogrel 3 Aspirin Tablets Aspirin + Ticagrelor 1 Aspirin Tablets Aspirin + Placebo 3 Ticagrelor Tablets Aspirin + Ticagrelor
- Primary Outcome Measures
Name Time Method Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose At 2 hours after first 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.
Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug 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.
- Secondary Outcome Measures
Name Time Method Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose 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.
Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose 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.
Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose 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.
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 6-week post treatment FEV1 is measured by Spirometry, the unit is Liter.
Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose 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.
Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose 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.
Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose 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.
Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose 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.
Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) Baseline FEV1 is measured by Spirometry, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) Baseline FVC is measured by Spirometry, the unit is Liter.
Cardiopulmonary Parameters at Post 6-week Treatment: FVC 6-week post treatment FVC is measured by Spirometry, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) Baseline FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio 6-week post treatment FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) Baseline FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 6-week post treatment FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) Baseline FRC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters Post 6-week Treatment: FRC 6-week post treatment FRC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) Baseline TLC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters Post 6-week Treatment: TLC 6-week post treatment TLC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Residual Volume (RV) Baseline RV is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters Post 6-week Treatment: RV 6-week post treatment RV is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) Baseline VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Cardiopulmonary Parameters Post 6-week Treatment: VE 6-week post treatment VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) Baseline RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Cardiopulmonary Parameters Post 6-week Treatment: RR 6-week post treatment RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) Baseline VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Cardiopulmonary Parameters Post 6-week Treatment: VT 6-week post treatment VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) Baseline DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB 6-week post treatment DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) Baseline 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.
Cardiopulmonary Parameters Post 6-week Treatment: EF 6-week post treatment 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.
Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Baseline NT-proBNP is measured by clinical lab, the unit is pg/mL.
Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP 6-week post treatment NT-proBNP is measured by clinical lab, the unit is pg/mL.
Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) Baseline SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Cardiopulmonary Parameters Post 6-week Treatment: SpO2 6-week post treatment SpO2 is measured by pulse oximetry, the unit is Percent. The unit % is the percentage of oxygen attached hemoglobin relative to the total hemoglobin.
Trial Locations
- Locations (1)
Research Site
🇬🇧Sheffield, United Kingdom