Table III. .
Mean bleeding times following multiple dosing of ticagrelor ± once-daily aspirin and clopidogrel with once-daily aspirin.
| Method/treatment | Bleeding time, mean ± SD (range)† |
|---|---|
| Study A (n = 13–16)a | |
| Simplate method | |
| Baseline (at enrolment) | 274 ± 64 (120–390) |
| Ticagrelor (50 mg bidb) | 1376 ± 527 (540–1800) |
| Ticagrelor/aspirin (50 mg bidb/300 mg qd) | 1622 ± 377 (720–1800) |
| Ticagrelor (200 mg bid§) | 1800 ± 0 (1800–1800) |
| Ticagrelor/aspirin (200 mg bid§/300 mg qd) | 1800 ± 0 (1800–1800) |
| Lancet method | |
| Baseline (at enrolment) | 159 ± 54 (53–240) |
| Ticagrelor (200 mg bid§) | 250 ± 77 (135–435) |
| Ticagrelor/aspirin (200 mg bid§/300 mg qd) | 541 ± 469 (195–1800) |
| Study B (n = 8–16) | |
| Lancet method | |
| Baseline (at screening) | 2.2 ± 0.7 (1.1–3.0) |
| Aspirin (300/75 mg qdc) | |
| 4 h post-dose on Day 3 | 2.7 ± 0.6 (2.0–3.8) |
| Pre-dose on Day 4 | 2.2 ± 0.4 (1.5–2.8) |
| Ticagrelor/aspirin (200 mg bidd/75 mg qd) | |
| Pre-dose | 13.1 ± 10.0 (2.5–30.0) |
| 4 h post-dose | 8.7 ± 8.4 (2.3–30.0) |
| Clopidogrele/aspirin (75 mg qd/75 mg qd) | |
| Pre-dose | 4.4 ± 1.5 (2.0–8.1) |
| 4 h post-dose | 4.8 ± 1.9 (2.0–8.5) |
bid = twice daily; h = hours; qd = once daily; SD = standard deviation.
a
Time point = 4 hours post-dosing, except for baseline values;†bleeding times are in seconds for Study A, and minutes for Study B.
b
50 mg bid for 5 days; §200 mg bid for 4 days then a single 200 mg dose for one day.
c
Loading dose 300 mg on day 1 then 75 mg qd thereafter.
d
200 mg bid for 5 days then a single 200 mg dose for one day.
e
300 mg for one day then 75 mg qd for 5 days.