Phase 2
Completed N=139
An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease
Source: ClinicalTrials.gov NCT01118325 ↗Enrolled (actual)
139
Serious AEs
2.2%
Results posted
Apr 2012
Primary outcomePrimary: Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients — 64.5; 73.0; 38.9 percentage inhibition
Summary
The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inhibition of Platelet Aggregation(IPA) Final Extent at 2 Hours Post Dose on Week 4 in Japanese Patients |
64.5; 73.0; 38.9 | — |
| PRIMARY IPA Final Extent at 4 Hours Post Dose on Week 4 in Japanese Patients |
67.3; 73.2; 43.7 | — |
| PRIMARY IPA Final Extent at 8 Hours Post Dose on Week 4 in Japanese Patients |
62.7; 68.6; 42.5 | — |
| PRIMARY IPA Final Extent at 12 Hours Post Dose on Week 4 in Japanese Patients |
56.9; 66.8; 41.8 | — |
| PRIMARY IPA Final Extent at 24 Hours Post Dose on Week 4 in Japanese Patients |
46.2; 59.1; 38.0 | — |
| SECONDARY AZD6140 (Cmax) at Week 4 |
422; 341; 931; 1380 | — |
| SECONDARY AZD6140 (AUC0-tau) at Week 4 |
3050; 2930; 6080; 10900 | — |
| SECONDARY AZD6140 (Tmax) at Week 4 |
2.0; 4.0; 2.0; 4.0 | — |
| SECONDARY AR-C124910XX (Cmax) at Week 4 |
135; 101; 326; 381 | — |
| SECONDARY AR-C124910XX (AUC0-tau) at Week 4 |
1180; 954; 2720; 3380 | — |
| SECONDARY AR-C124910XX (Tmax) at Week 4 |
4.0; 4.0; 2.1; 2.0 | — |
Eligibility Criteria
Inclusion Criteria
- Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
- Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
- Treatment with ASA
Exclusion Criteria
- ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
- Known concurrent disease of stroke or TIA with atrial fibrillation
- Persons who are being treated with blood clotting agents that cannot be stopped
Data sourced from ClinicalTrials.gov (NCT01118325). 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. Informational only — not medical advice.