To evaluate and compare the change of plaque composition by VH-IVUS imaging in subjects who take NXT and placebo in post-PCI of AMI patients during 12 months follow-up.
NXT-ASSESS is a placebo controlled,double-blind,randomised trial for assessment of the efficacy of Naoxingtong capsules in the treatment of coronary atherosclerotic plaque in patients with acute myocardial infarct on the basis of optimal medical therapy.A total of approximately 80 AMI patients with selective PCI indication who take NXT and placebo in post-PCI 12 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Patients with acute myocardial infarct on the basis of optimal medical therapy will take Naoxintong capsules following directions for 12 months
Patients with acute myocardial infarct on the basis of optimal medical therapy will take placebo following directions for 12 months
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, China
Plaque composition
The change of plaque composition by virtual histology intravascular ultrasound imaging in subjects who take Naoxintong capsules and placebo in post-percutaneous coronary intervention follow-up
Time frame: 12 months
Plaque fibrous cap thickness
The change of plaque fibrous cap thickness measured by optical coherence tomography in subjects who take Naoxintong capsules and placebo during post-percutaneous coronary intervention follow-up
Time frame: 12 months
Lipid arc
The change of lipid arc measured by optical coherence tomography in subjects who take Naoxintong capsules and placebo in post-percutaneous coronary intervention follow-up
Time frame: 12 months
Percent atheroma volume
The change of percent atheroma volume measured by intravascular ultrasound imaging in subjects who take Naoxintong capsules and placebo capsules during post-percutaneous coronary intervention follow-up
Time frame: 12 months
Total atheroma volume and low attenuation plaque volume
Total atheroma volume and low attenuation plaque volume measured by Coronary-CTA in subjects who take Naoxintong and placebo capsules during post-percutaneous coronary intervention follow-up
Time frame: 12 months
Lipid
The change of lipid measured by optical coherence tomography in subjects who take Naoxintong capsules
Time frame: 12 months
Platelet function
The change of platelet function measured by optical coherence tomography in subjects who take Naoxintong capsules
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Time frame: 12 months
Clinical incidents
The number of clinical incidents in subjects who take Naoxintong capsules
Time frame: 12 months
Culprit vessel
The change of subjects culprit vessel with optical coherence tomography;
Time frame: 12 months