Chinese People's Liberation Army General Hospital
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- the prevalence of no-reflow,
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ticagrelor Group
ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery
Intervention: Ticagrelor (Drug)
Clopidogrel Group
Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery
Intervention: Clopidogrel (Drug)
Outcomes
Primary Outcomes
the prevalence of no-reflow,
Time Frame: immediately post procedure
Anterograde coronary flow in the infarct-related artery was graded according to the thrombolysis in myocardial infarction (TIMI) grading system
Secondary Outcomes
- main cardiovascular events(90 days)
Investigators
Qian geng
associate chief physician
Chinese PLA General Hospital