Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial

Table 1 Schedule of events

Variable	Baseline	Post-procedure	Follow-up
			30 days	3 months
			± 2 weeks	± 1 month
Medical/clinical history (age, sex, risk factors, clinical diagnosis, angina status, cardiac history)	X
Informed consent^a	X
Inclusion/exclusion criteria	X
Brief physical examination	X
Vital status	X		X	X
Weight, height	X
12-lead ECG^b	X	X		X
Angiogram^c	X
IMR examination		X
CBC	X			X
Electrolytes, LFT	X			X
Creatinine, BUN	X			X
hs-CRP	X			X
Fasting plasma triglycerides, HDL cholesterol, total cholesterol	X			X
Fasting glucose level^d	X			X
HbA1c^e	X			X
Medications	X		X	X
CK, CK-MB, troponin I^f	X	X
proBNP	X			X
Echocardiography	X			X

^aThe informed consent will be signed either prior to or after the diagnostic angiogram; ^badditional ECGs will be performed at 60 ± 30 minutes post-procedure. ECG at follow-up visits will only be obtained when clinically indicated by symptoms such as recurrent chest pain, ischemia or significant arrhythmias, heart failure or other signs or symptoms of clinical instability; ^croutine follow-up angiography will be recommended at 9 months, but it can be performed at 9 months ± 2 months. Unscheduled angiograms ≥6 months after index procedure will be considered as the 9-month follow-up angiogram in final analysis; ^dmight be measured later, before discharge, when the patient is in a fasting state; ^ewill be performed in patients with diagnosed diabetes mellitus; ^fcardiac enzyme levels should be followed up for at least 24 hours in patients with symptoms such as recurrent chest pain, ischemia, significant arrhythmias, heart failure or other clinical signs or symptoms of cardiac instability. Otherwise, the decision is up to the operator. If follow-up is performed, enzyme levels must be measured every 8 hours for at least 24 hours post-index procedure. BUN, blood urea nitrogen; CBC, complete blood count; CK, creatine kinase; ECG, electrocardiogram; HbA1c, hemoglobin A1c; HDL, high-density lipoprotein; hs-CRP, high sensitivity C-reactive protein; IMR, index of microcirculatory resistance; LFT, liver function test; pro-BNP, pro-brain natriuretic peptide.

ISSN: 1745-6215