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Study to see if platelet transfusion stop or lessen the effect of the drug on platelets
A open label, randomized, crossover and potential parallel, single dose study of ticagrelor 180 mg and acetylsalicylic acid (ASA) in healthy volunteers followed by autologous in vivo platelet transfusion to determine the effects of platelet supplementation on the reversibility of platelet inhibition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Ticagrelor with Platelet transfusion |
|
| 2 | Experimental | Ticagrelor without Platelet transfusion |
|
| 3 | Active Comparator | Clopidogrel with Platelet transfusion |
|
| 4 | Active Comparator | Clopidogrel without Platelet transfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | Oral single loading dose 180ng |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Ticagrelor | Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNowâ„¢ after loading dose of Ticagrelor | Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h | |
| Pharmacodynamics in terms of platelet reactivity as measured by P2Y12 Reaction Units (PRU) using VerifyNowâ„¢ after loading dose of Clopidogrel |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Carlson, MD | AstraZeneca Wilmington US | Study Chair |
| Phil Leese, MD | Overland Park US, Quintiles, Inc | Principal Investigator |
| Judi Hsia, MD | Wilmington, US AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Clopidogrel |
| Drug |
Oral single loading dose 600mg |
|
| ASA | Drug | 81mg once daily from day -2 up to platelet transfusion |
|
| Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h |
| Pharmacodynamics in terms of percent of inhibition of adenosine phosphatase (ADP)-induced platelet aggregation assessed by light transmission aggregometry (LTA) after loading dose of Clopidogrel | Predose, 0h, 2h,6h,12h,24h,36h,48h,60h,72h,84h and 96h |
| Safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables | up to 9 weeks |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |