Effects of Ticagrelor on No-reflow in Patients With Acute ST-segment Elevation Myocardial Infarction

Study Overview
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Brief Summary
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The 'no-reflow' phenomenon after a percutaneous coronary intervention (PCI) in patients with acute ST-segment elevation myocardial infarction (STEMI) is a strong predictor of both short- and long-term mortality. Faster antiplatelet activity and increased levels of adenosine provide a theoretical basis for ticagrelor to effectively prevent no-reflow after PCI. We planned to evaluate the effects of ticagrelor on myocardial no-reflow after PCI for STEMI.

Detailed Description
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Investigators enrolled 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between September 2013 and March 2015. STEMI was defined as typical chest pain lasting N30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T. We screen high-risk patients through no-reflow risk prediction model， patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions. We randomly assigned eligible patients in a 1:1 ratio to receive either ticagrelor 180 mg or clopidogrel 600 mg 30 min before PCI. The primary efficacy variable was the prevalence of no-reflow assessed immediately post procedure. Secondary efficacy variables were troponin T (TnT), high sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), superoxide dismutase (SOD), malondialdehyde (MDA), endothelin-1 (ET-1), and nitric oxide (NO) level

Official Title
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Chinese People's Liberation Army General Hospital

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with STEMI who were admitted to the Chinese PLA General Hospital Exclusion Criteria: 1.unconscious at presentation; 2.had cardiogenic shock, 3.hypoglycemia, 4.diabetic ketoacidosis; 5.had a history of myocardial infarction, stent thrombosis, or renal insufficiency; 6.had previously undergone coronary artery bypass surgery.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor Group<br>ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery | Drug: Ticagrelor<br>* ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery<br>|
| Active Comparator: Clopidogrel Group<br>Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery | Drug: Clopidogrel<br>* Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prevalence of no-reflow, | Anterograde coronary flow in the infarct-related artery was graded according to the thrombolysis in myocardial infarction (TIMI) grading system | immediately post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| main cardiovascular events | bleeding, dialysis, myocardial infarction, heart failure and all-cause death | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, No-reflow, Acute ST-segment elevation myocardial, Reperfusion injury, Percutaneous coronary intervention