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

Not Applicable

• Conditions: Cardiovascular Diseases
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT02798874
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-13
• Last Update Submitted: 2016-06-13
• Study First Posted: 2016-06-14
• Last Update Posted: 2016-06-14
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ticagrelor Group	Ticagrelor	ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery
Clopidogrel Group	Clopidogrel	Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
main cardiovascular events	90 days	bleeding, dialysis, myocardial infarction, heart failure and all-cause death

Trial Locations

Locations (1)

Chinese People's Liberation Army General Hospital; 🇨🇳 Peking, Beijing, China