Table 3.
The five elements of the outcomes
| Domain | Specific measurement | Specific metric | Method of aggregation | Time-points |
|---|---|---|---|---|
| Primary outcome | ||||
| Stable angina symptom score | Symptom score standard classification [22] | Difference between two groups | Proportion | Baseline, 28 days after treatment |
| Secondary outcomes | ||||
| ECG parameters | Classification of 12-lead ECG improvement [23] | Difference between two groups | Proportion | Baseline, 28 days after treatment |
| SAQ scores | SAQ [24] | Difference in the change between groups | Mean/ median | Baseline, 28 days after treatment |
| Nitroglycerin consumption | Count | Compare the difference between groups | Median | Baseline, 28 days after treatment |
| Safety outcomes | ||||
| Vital signs | Heart rate, respiration, body temperature, blood pressure | Compare the difference between groups | Mean/ median | Run-in period, baseline, 28 days after treatment |
| Clinical laboratory tests | Routine blood test, routine urinalysis, serum biochemistry, blood coagulation index, and fasting blood glucose | Compare the difference between groups | Mean/ median | Baseline, 28 days after treatment |
| AEs, SAEs | Common Terminology Criteria for AEs version 4.03. | Compare the difference between groups | Proportion | Baseline, 28 days after treatment |
ECG electrocardiogram, SAQ Seattle Angina Questionnaire