| |
STUDY PERIOD
|
|---|
|
Enrollment
|
allocation
|
Post-allocation
|
Close-out
|
|---|
|
Time point**
| |
0
|
day 1
|
in-hospital
|
at discharge
|
day 30
|
1 year
|
|
Enrollment:
| | | | | | | |
|
Eligibility screen
|
X
| | | | | | |
|
Informed consent
|
X
| | | | | | |
|
History and ECG
|
X
| | | | | | |
|
Allocation
| |
X
| | | | | |
|
Interventions:
| | | | | | | |
|
Medical treatment*
| | |
X
| | | | |
|
Invasive treatment strategy
| | | |
X
| | | |
|
Assessments:
| | | | | | | |
|
Echocardiography and frailty score
|
X
| | | | | | |
|
QoL and angina questionnaire
|
X
| | | | | |
X
|
|
Adverse events
| | | |
X
|
X
|
X
|
X
|
|
If symptoms, additional assessments**
| | | | |
X
|
X
|
X
|
|
Outcome:
| | | | | | | |
|
MACCE***
| | | | | |
X
|
X§
|
|
Myocardial infarction
| | | | | | |
X
|
|
All-cause mortality
| | | | | | |
X
|
|
Safety measure: bleeding
| | | |
X
|
X
|
X
|
X
|
- *Medical treatment will be given to all study participants regardless of treatment allocation, provided that there are no contraindications.
- **If symptoms of ischemia: ECG, CK-MB, and cardiac troponins. If symptoms of bleeding: hemoglobin and platelet count.
-
*** Combined endpoint: MACCE: major adverse cardiac or cerebral event.
-
§Primary endpoint of the study.
- QoL: Quality of life, ECG: Electrocardiogram.
