Period | Run-in period | Treatment period | Follow-up period | ||||
---|---|---|---|---|---|---|---|
Day | −7 | 0 | 7 | 14 | 30 | 60 | 90 |
Informed consent | × | × |  |  |  |  |  |
Inclusion or exclusion criteria | × | × |  |  |  |  |  |
Medical history | × | × |  |  |  |  |  |
Medical examination | × |  |  |  |  |  |  |
Combined disease treatment | × | × | × | × | × | × | × |
Outcome measures: | Â | Â | Â | Â | Â | Â | Â |
Proportion of patients who have a clinically significant change as defined by Seattle Angina Questionnaire: angina frequency score |  | × |  |  | × | × | × |
Symptom questionnaire of traditional Chinese medicine |  | × | × | × | × | × | × |
The other four Seattle Angina Questionnaire scales |  | × | × | × | × | × | × |
Frequency of anginal attack per week | × | × | × | × | × | × | × |
Canadian Cardiovascular Society grade |  | × | × | × | × | × | × |
Consumption of short-acting nitrates | × | × | × | × | × | × | × |
Electrocardiogram |  | × | × | × | × | × | × |
Serum lipids |  | × |  | × |  |  |  |
High-sensitivity C-reactive protein |  | × |  | × |  |  |  |
Platelet aggregation rate |  | × |  | × |  |  |  |
New-onset major vascular events |  |  |  |  |  |  | × |
Overall mortality |  |  |  |  |  |  | × |
Incidence of severe haemorrhage |  |  |  |  |  |  | × |
Incidence of moderate haemorrhage |  |  |  |  |  |  | × |
Adverse and serious adverse events |  |  | × | × | × | × | × |
Exercise tolerance test (if necessary after 1st interim analysis) |  | × |  | × |  |  |  |
Profiles of micro-RNA in 60 patients in certain centres |  | × |  | × |  |  | × |
Profiles of mRNA in 60 patients in certain centres |  | × |  | × |  |  | × |