Table 2.
Study endpoints
| Primary efficacy endpoint |
|---|
| Composite of all‐cause death, strokea (primary definitionb), and major bleeding (ISTH definition) |
| Primary safety endpoint |
| Major bleeding (ISTH definition) |
| Secondary efficacy endpoints |
| Composite of all‐cause death, strokea (alternative definitionc), and major bleeding (ISTH definition) |
| Composite of stroke,a SEE, and CV mortality |
| Composite of stroke,a SEE, and all‐cause mortality |
| Composite of strokea and TIA |
| Strokea |
| Ischemic stroke |
| Hemorrhagic stroke |
| Undetermined stroke |
| SEE |
| TIA |
| Fatal strokea |
| Nonfatal strokea |
| Disabling strokea |
| Nondisabling strokea |
| Secondary safety endpoints |
| Major bleeding (defined by TIMI, BARC [≥2]) |
| Major or CRNM bleeding (defined by ISTH) |
| CRNM bleeding (ISTH definition) |
| Minor bleeding (ISTH definition) |
| Any bleeding |
| ICH |
| Life‐threatening bleeding |
| Fatal major bleeding (ISTH definition) |
| Nonfatal major bleeding (ISTH definition) |
| Fatal major bleeding (defined by TIMI, BARC [≥2]) |
| Nonfatal major bleeding (defined by TIMI, BARC [≥2]) |
| Safety parameters |
| Other endpoints |
| Relevant HEOR parametersd |
| Silent cerebral lesions as defined by DW‐MRIe |
| Cardiac markers (including NT‐proBNP and hs‐cTn) |
Abbreviations: BARC, Bleeding Academic Research Consortium; CRNM, clinically relevant nonmajor; CV, cardiovascular; DW‐MRI, diffusion‐weighted magnetic resonance imaging; HEOR, health economics and outcomes research; hs‐cTn, high‐sensitivity cardiac troponin; ICH, intracranial hemorrhage; ISTH, International Society on Thrombosis and Haemostasis; NT‐proBNP, N‐terminal pro B‐type natriuretic peptide; SEE, systemic embolic events; TIA, transient ischemic event; TIMI, Thrombolysis In Myocardial Infarction.
Includes ischemic, hemorrhagic, and undetermined.
Acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Stroke is distinguished from TIA if the duration of neurological dysfunction is >24 hours, the duration is <24 hours, and there is imaging documenting new hemorrhage or infarction, or if the neurological dysfunction results in death.
Abrupt onset of a focal neurological deficit in the distribution of a single brain artery that is not due to an identifiable nonvascular cause and that either lasts ≥24 hours or results in death within 24 hours of onset.
Includes cancellations of ablation procedure due to inadequate anticoagulation, hospital admissions due to CV causes, length of stay associated with the different types of hospital admissions, and additional outpatient physician or nurse visits that are CV event‐related.
At predetermined select sites.