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A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ticagrelor Tablets
Clopidogrel (over encapsulated) capsule
Aspirin Tablets
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery disease, CAD, heart attack, stable angina, Stable coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

1

2

3

Arm Description

Aspirin + Placebo

Aspirin + clopidogrel

Aspirin + Ticagrelor

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is measured by Spirometry, the unit is Liter.
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
FEV1 is measured by Spirometry, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
FVC is measured by Spirometry, the unit is Liter.
Cardiopulmonary Parameters at Post 6-week Treatment: FVC
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)
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
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)
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
FRC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters Post 6-week Treatment: FRC
FRC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
TLC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters Post 6-week Treatment: TLC
TLC is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
RV is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters Post 6-week Treatment: RV
RV is measured by Body Box Plethysmography, the unit is Liter.
Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Cardiopulmonary Parameters Post 6-week Treatment: VE
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Cardiopulmonary Parameters Post 6-week Treatment: RR
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Cardiopulmonary Parameters Post 6-week Treatment: VT
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)
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
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.
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.
Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
NT-proBNP is measured by clinical lab, the unit is pg/mL.
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.
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.

Full Information

First Posted
September 10, 2007
Last Updated
January 12, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00528411
Brief Title
A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin
Official Title
A Multi-centre Randomised, Double-blind, Double-dummy Parallel Group Study of the Onset and Offset of Antiplatelet Effects of Ticagrelor Compared With Clopidogrel and Placebo With Aspirin as Background Therapy in Patients With Stable Coronary Artery Disease (CAD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, CAD, heart attack, stable angina, Stable coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Aspirin + Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Aspirin + clopidogrel
Arm Title
3
Arm Type
Experimental
Arm Description
Aspirin + Ticagrelor
Intervention Type
Drug
Intervention Name(s)
Ticagrelor Tablets
Intervention Description
Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)
Intervention Type
Drug
Intervention Name(s)
Clopidogrel (over encapsulated) capsule
Other Intervention Name(s)
Plavix, Clopidogrel Bisulfate
Intervention Description
Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)
Intervention Type
Drug
Intervention Name(s)
Aspirin Tablets
Other Intervention Name(s)
ASA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose
Description
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
Title
Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug
Description
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
Secondary Outcome Measure Information:
Title
Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose
Description
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
Title
Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose
Description
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
Title
Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)
Description
FEV1 is measured by Spirometry, the unit is Liter.
Time Frame
Baseline
Title
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1
Description
FEV1 is measured by Spirometry, the unit is Liter.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)
Description
FVC is measured by Spirometry, the unit is Liter.
Time Frame
Baseline
Title
Cardiopulmonary Parameters at Post 6-week Treatment: FVC
Description
FVC is measured by Spirometry, the unit is Liter.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)
Description
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time Frame
Baseline
Title
Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio
Description
FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)
Description
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75
Description
FEF25-75 is measured by Spirometry, the unit is Liter/Second.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)
Description
FRC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: FRC
Description
FRC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)
Description
TLC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: TLC
Description
TLC is measured by Body Box Plethysmography, the unit is Liter.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Residual Volume (RV)
Description
RV is measured by Body Box Plethysmography, the unit is Liter.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: RV
Description
RV is measured by Body Box Plethysmography, the unit is Liter.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)
Description
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: VE
Description
VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)
Description
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: RR
Description
RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)
Description
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: VT
Description
VT is measured by Body Box Plethysmography, the unit is Liter/Minute.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)
Description
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB
Description
DLCOSB is measured by Body Box Plethysmography, the unit is Percent.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)
Description
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
Title
Cardiopulmonary Parameters Post 6-week Treatment: EF
Description
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
Title
Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)
Description
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time Frame
Baseline
Title
Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP
Description
NT-proBNP is measured by clinical lab, the unit is pg/mL.
Time Frame
6-week post treatment
Title
Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)
Description
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
Title
Cardiopulmonary Parameters Post 6-week Treatment: SpO2
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Sager, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Gurbel, MD
Organizational Affiliation
Platelet & Thrombosis Research, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Towson
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22795280
Citation
Jeong YH, Bliden KP, Antonino MJ, Park KS, Tantry US, Gurbel PA. Usefulness of the VerifyNow P2Y12 assay to evaluate the antiplatelet effects of ticagrelor and clopidogrel therapies. Am Heart J. 2012 Jul;164(1):35-42. doi: 10.1016/j.ahj.2012.03.022. Epub 2012 Jun 13.
Results Reference
derived
PubMed Identifier
22212857
Citation
Jeong YH, Bliden KP, Tantry US, Gurbel PA. High on-treatment platelet reactivity assessed by various platelet function tests: is the consensus-defined cut-off of VASP-P platelet reactivity index too low? J Thromb Haemost. 2012 Mar;10(3):487-9. doi: 10.1111/j.1538-7836.2011.04604.x. No abstract available.
Results Reference
derived
PubMed Identifier
21079055
Citation
Tantry US, Bliden KP, Wei C, Storey RF, Armstrong M, Butler K, Gurbel PA. First analysis of the relation between CYP2C19 genotype and pharmacodynamics in patients treated with ticagrelor versus clopidogrel: the ONSET/OFFSET and RESPOND genotype studies. Circ Cardiovasc Genet. 2010 Dec;3(6):556-66. doi: 10.1161/CIRCGENETICS.110.958561. Epub 2010 Nov 15.
Results Reference
derived
PubMed Identifier
20620737
Citation
Storey RF, Bliden KP, Patil SB, Karunakaran A, Ecob R, Butler K, Teng R, Wei C, Tantry US, Gurbel PA; ONSET/OFFSET Investigators. Incidence of dyspnea and assessment of cardiac and pulmonary function in patients with stable coronary artery disease receiving ticagrelor, clopidogrel, or placebo in the ONSET/OFFSET study. J Am Coll Cardiol. 2010 Jul 13;56(3):185-93. doi: 10.1016/j.jacc.2010.01.062.
Results Reference
derived
PubMed Identifier
19923168
Citation
Gurbel PA, Bliden KP, Butler K, Tantry US, Gesheff T, Wei C, Teng R, Antonino MJ, Patil SB, Karunakaran A, Kereiakes DJ, Parris C, Purdy D, Wilson V, Ledley GS, Storey RF. Randomized double-blind assessment of the ONSET and OFFSET of the antiplatelet effects of ticagrelor versus clopidogrel in patients with stable coronary artery disease: the ONSET/OFFSET study. Circulation. 2009 Dec 22;120(25):2577-85. doi: 10.1161/CIRCULATIONAHA.109.912550. Epub 2009 Nov 18.
Results Reference
derived

Learn more about this trial

A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin

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