Atherosclerotic Cardiovascular DiseaseNXT-ASSESSNCT05278182
A Study for Exploring the Efficacy of Naoxintong Capsules in the Treatment of Coronary Atherosclerotic Plaque on the Basis of Optimal Medical Therapy (Aspirin,Statins,Clopidogrel, Etc.): Stage One
A study testing Naoxintong Capsule in people with Atherosclerotic Cardiovascular Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Naoxintong Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing informed consent;
- Male or female aged 18 to 75 years old;
- AMI patients with selective PCI indication primary PCI patients are exclusive;
- No history of CABG or PCI;
- Image inclusion criteria:
- CCTA at least one in-segment ≥20% and ≤70% diameter stenosis non-culprit vessel in the proximal-middle segments of RCA, LCX, LAD (the proximal and distal plaque within 5mm, same as below);
- Radiography diameter of target vessel, 2.5-4.0mm;
- Studied vessel can be evaluated with OCT and IVUS; OCT: the visual target study lesion is lipid-rich plaque with lipid arc≥100 degree and fiber cap thickness≤120µm.
Who cannot join
- Life expectancy is less than 1 year;
- Cannot implant drug stent;
- Received ≥4weeks systematic treatment of statin and other lipid-lowering drug in the 3 months before admission;
- Received ≥4 weeks systematic treatment of any traditional Chinese medicine;
- Known to have adverse reaction to ingredients of NXT capsule;
- Patients with severe heart disease that CABG or selective PCI, heart transplantationSAVR/TAVR are required during the study(12 months);
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- LVEF<40%;
- Drug uncontrollable recurrent and highly symptomatic arrhythmia such as ventricular tachycaidia, atrial fibrillation with rapid ventricular rate and paroxysmal supraventricular tachycardia in the 3 months before ACS admission;
- Known any stroke;
- Other operations arranged during the study period (12 months);
- Uncontrollable hypertension, defined as resting systolic BP≥180mmHg;
- Clinical confirmed as statin intolerance;
- Type I diabetes or type 2 diabetes that is not well controlled;
- Moderate and severe renal dysfunction (defined as eGFR<30ml/min/1.73m2);
- Clinical confirmed liver disease or liver dysfunction (AST or ALT >3*ULN);
- Clinical confirmed infection and other hematological, metabolic gastrointestinal or endocrine dysfunction that researchers believe not suitable for enrollment;
- Known factors that may not be compliant, such as alcoholism, drug addiction, mental illness, etc.;
- Participated in other clinical research projects, or within 30 days of the last participating clinical project;
- Pregnant,breast feeding women or those plan to conceive during the study;
- History of malignant tumor.
- Lesion related:
- Target segment severe calcification;
- Failed PCI in culprit vessel;
- Failed OCT screening (lipid arc/ fiber cap thickness does not match filter criteria);
- Complications during the evaluation of OCT and IVUS/VH-IVUSOCT and IVUS/VH-IVUS evaluation failed due to instruments.
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing, Beijing Municipality, 100010
Qian Jie, +86 13601396650, qianjfw@163.com
About this study
Official title: A Placebo Controlled, Double-blind, Randomised Trial for Assessment of the Efficacy of Naoxintong Capsules in the Treatment of Coronary Atherosclerotic Plaque in Patients With Acute Myocardial Infarct on the Basis of Optimal Medical Therapy (Aspirin,Statins, Clopidogrel, Etc.)
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.
Read the detailed description
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
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Naoxintong Capsule, Placebo
- Keywords
- on the Basis of Optimal Medical Therapy
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naoxintong CapsuleDrug
Patients with acute myocardial infarct on the basis of optimal medical therapy will take Naoxintong capsules following directions for 12 months
PlaceboDrug
Patients with acute myocardial infarct on the basis of optimal medical therapy will take placebo following directions for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Naoxintong Capsule | Experimental | Naoxintong Capsule Receives: Drug: Naoxintong Capsule |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 12 months
Lipid
The change of lipid measured by optical coherence tomography in subjects who take Naoxintong capsules
Measured: 12 months
Platelet function
The change of platelet function measured by optical coherence tomography in subjects who take Naoxintong capsules
Measured: 12 months
Clinical incidents
The number of clinical incidents in subjects who take Naoxintong capsules
Measured: 12 months
Culprit vessel
The change of subjects culprit vessel with optical coherence tomography;
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study startDec 2022 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Runlin Gao, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278182
- Sponsor's protocol ID
- CRFH20180010
- Acronym
- NXT-ASSESS
- Status last verified
- May 2022
- First submitted
- 6 Feb 2022
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Double-blind, Randomised Trial for Assessment of the Efficacy of Naoxintong Capsules in the Treatment of Coronary Atherosclerotic Plaque in Patients With Acute Myocardial Infarct on the Basis of Optimal Medical Therapy (Aspirin,Statins, Clopidogrel, Etc.)
- ClinicalTrials.gov ID
- NCT05278182
- Acronym / sponsor ID
- NXT-ASSESS / CRFH20180010
- Conditions
- Atherosclerotic Cardiovascular Disease
- Keywords
- on the Basis of Optimal Medical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naoxintong Capsule | Experimental | Drug: Naoxintong CapsuleNaoxintong Capsule |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signing informed consent;
- Male or female aged 18 to 75 years old;
- AMI patients with selective PCI indication primary PCI patients are exclusive;
- No history of CABG or PCI;
- CCTA at least one in-segment ≥20% and ≤70% diameter stenosis non-culprit vessel in the proximal-middle segments of RCA, LCX, LAD (the proximal and distal plaque within 5mm, same as below);
Key exclusion criteria (25 listed)
- Life expectancy is less than 1 year;
- Cannot implant drug stent;
- Received ≥4weeks systematic treatment of statin and other lipid-lowering drug in the 3 months before admission;
- Received ≥4 weeks systematic treatment of any traditional Chinese medicine;
- Known to have adverse reaction to ingredients of NXT capsule;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naoxintong CapsulePatients with acute myocardial infarct on the basis of optimal medical therapy will take Naoxintong capsules following directions for 12 months | Drug | Naoxintong Capsule |
| PlaceboPatients with acute myocardial infarct on the basis of optimal medical therapy will take placebo following directions for 12 months | Drug | Placebo |
Primary outcome
Plaque composition
Time frame: 12 months
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
Plaque fibrous cap thickness
Time frame: 12 months
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
7 secondary outcomes
Lipid arc
Time frame: 12 months
Percent atheroma volume
Time frame: 12 months
Total atheroma volume and low attenuation plaque volume
Time frame: 12 months
Lipid
Time frame: 12 months
Platelet function
Time frame: 12 months
Clinical incidents
Time frame: 12 months
Culprit vessel
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naoxintong Capsule in people with Atherosclerotic Cardiovascular Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Jie (+86 13601396650, qianjfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque composition (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.