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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naoxintong Capsule | Experimental | Naoxintong Capsule |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naoxintong Capsule | Drug | Patients with acute myocardial infarct on the basis of optimal medical therapy will take Naoxintong capsules following directions for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Percent atheroma volume |
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Inclusion Criteria:
Image inclusion criteria:
Exclusion Criteria:
Lesion related:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jie | Contact | +86 13601396650 | qianjfw@163.com | |
| Runlin Gao, Prof | Contact | +86 13901207581 | gaorunlin@citmd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences, Fuwai Hospital | Beijing | Beijing Municipality | 100010 | China |
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| Placebo | Drug | Patients with acute myocardial infarct on the basis of optimal medical therapy will take placebo following directions for 12 months |
|
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
| 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 | 12 months |
| Lipid | The change of lipid measured by optical coherence tomography in subjects who take Naoxintong capsules | 12 months |
| Platelet function | The change of platelet function measured by optical coherence tomography in subjects who take Naoxintong capsules | 12 months |
| Clinical incidents | The number of clinical incidents in subjects who take Naoxintong capsules | 12 months |
| Culprit vessel | The change of subjects culprit vessel with optical coherence tomography; | 12 months |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C571443 | naoxintong |
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