Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02293395 | A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome | PHASE2 | COMPLETED | 3,037 | — | — | Apr 20, 2015 | Oct 14, 2016 | Dec 26, 2017 | 259 | United States, Argentina +18 |
Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - \<5 g/dl (or drop in hematocrit of 9 - \<15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.
| Arm | Type | Description |
|---|---|---|
| Stratum 1/ASA | ACTIVE_COMPARATOR | Acetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. |
| Stratum 1/Rivaroxaban | EXPERIMENTAL | Rivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. |
| Stratum 2/ASA | ACTIVE_COMPARATOR | ASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. |
| Stratum 2/Rivaroxaban | EXPERIMENTAL | Rivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. |
| Name | Type | Description |
|---|---|---|
| Acetylsalicylic acid | DRUG | ASA 100 mg enteric-coated tablet once daily orally. |
| Rivaroxaban | DRUG | Rivaroxaban 2.5 mg tablet twice daily orally. |
| Clopidogrel | DRUG | Clopidogrel 75 mg once daily orally. |
| Ticagrelor | DRUG | Ticagrelor 90 mg twice daily orally. |
Inclusion Criteria: * Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation m...