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Completed

NCT Number: NCT00528411

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

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.

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Sheffield, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor Tablets

Drug

Oral, 90 mg; 180 mg loading dose followed by 90 mg twice daily (BD)

Clopidogrel (over encapsulated) capsule

Drug

Oral 75 mg; 600 mg loading dose followed by 75 mg once daily (ODD)

Other names: Plavix, Clopidogrel Bisulfate

Aspirin Tablets

Drug

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.

Other names: ASA

Primary outcomes

  1. Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose

    Time frame: 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.

  2. Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug

    Time frame: 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 outcomes

  1. Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose

    Time frame: 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.

  2. Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose

    Time frame: 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.

  3. Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose

    Time frame: 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.

  4. Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose

    Time frame: 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.

  5. Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose

    Time frame: 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.

  6. Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose

    Time frame: 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.

  7. Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose

    Time frame: 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.

  8. Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose

    Time frame: 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.

  9. Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose

    Time frame: 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.

  10. Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose

    Time frame: 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.

  11. Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose

    Time frame: 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.

  12. Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose

    Time frame: 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.

  13. Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose

    Time frame: 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.

  14. Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose

    Time frame: 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.

  15. Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose

    Time frame: 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.

  16. Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline

    FEV1 is measured by Spirometry, the unit is Liter.

  17. Cardiopulmonary Parameters at Post 6-week Treatment: FEV1

    Time frame: 6-week post treatment

    FEV1 is measured by Spirometry, the unit is Liter.

  18. Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC)

    Time frame: Baseline

    FVC is measured by Spirometry, the unit is Liter.

  19. Cardiopulmonary Parameters at Post 6-week Treatment: FVC

    Time frame: 6-week post treatment

    FVC is measured by Spirometry, the unit is Liter.

  20. Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio)

    Time frame: Baseline

    FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.

  21. Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio

    Time frame: 6-week post treatment

    FEV1/FVC Ratio is measured by Spirometry, the unit is Ratio.

  22. Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75)

    Time frame: Baseline

    FEF25-75 is measured by Spirometry, the unit is Liter/Second.

  23. Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75

    Time frame: 6-week post treatment

    FEF25-75 is measured by Spirometry, the unit is Liter/Second.

  24. Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC)

    Time frame: Baseline

    FRC is measured by Body Box Plethysmography, the unit is Liter.

  25. Cardiopulmonary Parameters Post 6-week Treatment: FRC

    Time frame: 6-week post treatment

    FRC is measured by Body Box Plethysmography, the unit is Liter.

  26. Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC)

    Time frame: Baseline

    TLC is measured by Body Box Plethysmography, the unit is Liter.

  27. Cardiopulmonary Parameters Post 6-week Treatment: TLC

    Time frame: 6-week post treatment

    TLC is measured by Body Box Plethysmography, the unit is Liter.

  28. Cardiopulmonary Parameters at Baseline: Residual Volume (RV)

    Time frame: Baseline

    RV is measured by Body Box Plethysmography, the unit is Liter.

  29. Cardiopulmonary Parameters Post 6-week Treatment: RV

    Time frame: 6-week post treatment

    RV is measured by Body Box Plethysmography, the unit is Liter.

  30. Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE)

    Time frame: Baseline

    VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute

  31. Cardiopulmonary Parameters Post 6-week Treatment: VE

    Time frame: 6-week post treatment

    VE is measured by Spirometry and Body Box Plethysmography, the unit is Liter/Minute

  32. Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR)

    Time frame: Baseline

    RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.

  33. Cardiopulmonary Parameters Post 6-week Treatment: RR

    Time frame: 6-week post treatment

    RR is measured by Spirometry and Body Box Plethysmography, the unit is Breaths/Minute.

  34. Cardiopulmonary Parameters at Baseline: Tidal Volume (VT)

    Time frame: Baseline

    VT is measured by Body Box Plethysmography, the unit is Liter/Minute.

  35. Cardiopulmonary Parameters Post 6-week Treatment: VT

    Time frame: 6-week post treatment

    VT is measured by Body Box Plethysmography, the unit is Liter/Minute.

  36. Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB)

    Time frame: Baseline

    DLCOSB is measured by Body Box Plethysmography, the unit is Percent.

  37. Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB

    Time frame: 6-week post treatment

    DLCOSB is measured by Body Box Plethysmography, the unit is Percent.

  38. Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF)

    Time frame: 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.

  39. Cardiopulmonary Parameters Post 6-week Treatment: EF

    Time frame: 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.

  40. Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

    Time frame: Baseline

    NT-proBNP is measured by clinical lab, the unit is pg/mL.

  41. Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP

    Time frame: 6-week post treatment

    NT-proBNP is measured by clinical lab, the unit is pg/mL.

  42. Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2)

    Time frame: 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.

  43. Cardiopulmonary Parameters Post 6-week Treatment: SpO2

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 12, 2007
Registry last updated
Jan 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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