Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings. More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.

Official Title
-----------------
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study)

Conditions
-----------------
Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Clopidogrel
* Drug: Ticagrelor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females between the ages of 18 and 75 years STEMI patients treated with percutaneous coronary intervention Able to provide informed consent Exclusion Criteria: History of stroke or transient ischemic attack Platelet count < 100 000/μL Known Bleeding Diathesis Hematocrit <30% or >52% Severe Liver Dysfunction Renal Insufficiency (Creatinine Clearance < 30ml/min) Pregnant females Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clopidogrel<br>Clopidogrel 600mg loading | Drug: Clopidogrel<br>* Clopidogrel 600mg loading<br>|
| Experimental: Ticagrelor<br>Ticagrelor 180mg loading | Drug: Ticagrelor<br>* Ticagrelor 180mg loading<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of microcirculatory resistance (IMR) measured after successful coronary intervention |  | IMR will be immediately assessed after successful PCI patients within 48hr from admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wall motion score index on three month later TTE from index PCI |  | TTE will be assessed in all enrolled patients 3 month later from index PCI |