Phase 2
N=123
A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00528411 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose — 93.15; 31.05 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ticagrelor Tablets (Drug); Clopidogrel (over encapsulated) capsule (Drug); Aspirin Tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Final Extent Inhibition of Platelet Aggregation (IPA) Induced by 20 µM Adenosine Diphosphate (ADP) at 2 Hours After First Dose |
93.15; 31.05 | — |
| PRIMARY Slope of Extent IPA Offset Curve 4 to 72 Hours After Last Dose of Study Drug |
-1.037; -0.482 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 0.5 Hours After First Dose |
45.39; 4.71 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 1 Hour After First Dose |
86.71; 15.83 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 4 Hours After First Dose |
98.39; 40.87 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 8 Hours After First Dose |
96.99; 46.90 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 24 Hours After First Dose |
87.29; 49.64 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 0 Hour Before Last Dose |
74.53; 51.75 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 2 Hours After Last Dose |
91.49; 62.96 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 4 Hours After Last Dose |
96.10; 61.80 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 8 Hours After Last Dose |
88.31; 61.31 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 24 Hours After Last Dose |
55.18; 53.91 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 48 Hours After Last Dose |
30.94; 45.79 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 72 Hours After Last Dose |
11.76; 21.09 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 120 Hours - Day 5 After Last Dose |
0.0; 21.15 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 168 Hours - Day 7 After Last Dose |
0.0; 6.32 | — |
| SECONDARY Final Extent IPA Induced by 20 µM ADP at 240 Hours - Day 10 After Last Dose |
1.64; 0.98 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Forced Expiratory Volume in 1 Second (FEV1) |
2.79; 2.71; 2.94 | — |
| SECONDARY Cardiopulmonary Parameters at Post 6-week Treatment: FEV1 |
2.77; 2.74; 2.95 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Forced Vital Capacity (FVC) |
3.72; 3.73; 4.03 | — |
| SECONDARY Cardiopulmonary Parameters at Post 6-week Treatment: FVC |
3.70; 3.78; 3.98 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Ratio of Forced Expiratory Volume in 1 Second Over Forced Vital Capacity (FEV1/FVC Ratio) |
75.01; 73.04; 73.13 | — |
| SECONDARY Cardiopulmonary Parameters at Post 6-week Treatment: FEV1/FVC Ratio |
74.71; 72.84; 74.27 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Mean Forced Expiratory Flow Between 25% and 75% of the FVC (FEF25-75) |
2.88; 2.70; 2.50 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: FEF25-75 |
2.77; 2.67; 2.91 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Functional Residual Capacity (FRC) |
2.79; 2.89; 2.91 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: FRC |
2.73; 2.79; 2.75 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Total Lung Capacity (TLC) |
5.78; 5.83; 6.10 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: TLC |
5.70; 5.85; 5.96 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Residual Volume (RV) |
1.94; 2.01; 1.91 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: RV |
1.88; 1.97; 1.90 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Minute Ventilation (VE) |
12.92; 12.17; 12.06 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: VE |
13.69; 13.14; 11.45 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Respiratory Rate (RR) |
14.79; 14.15; 15.5 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: RR |
15.21; 15.10; 14.91 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Tidal Volume (VT) |
0.96; 0.89; 0.89 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: VT |
0.92; 0.93; 0.83 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Single Breath Diffusing Capacity for the Lungs Using Carbon Monoxide (DLCOSB) |
17.00; 17.29; 15.83 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: DLCOSB |
16.38; 16.53; 16.09 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Ejection Fraction (EF) |
57.96; 61.91; 59.92 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: EF |
60.70; 62.38; 60.73 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) |
163.34; 185.98; 145.41 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: NT-proBNP |
139.88; 214.43; 140.68 | — |
| SECONDARY Cardiopulmonary Parameters at Baseline: Blood Oxygen Saturation Measured by Pulse Oximetry (SpO2) |
96.59; 96.78; 97.58 | — |
| SECONDARY Cardiopulmonary Parameters Post 6-week Treatment: SpO2 |
97.73; 97.35; 98.56 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00528411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.