Coronary Atherosclerosis Clinical Trial
Official title:
A Comparative Study on Antiplatelet Efficacy of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
In addition, studies have found that indobufen can inhibit coagulation function in rats. Compared with aspirin, the duration of antiplatelet efficacy of indobufen was shorter, and the platelet function recovered completely 24 hours after drug withdrawal. However, there are few studies on the antiplatelet efficacy of indobufen. The investigators' previous study found that the inhibitory effect of indobufen 100 mg Bid on COX system in atherosclerosis or healthy volunteers was equivalent to that of aspirin 100 mg QD, but the inhibitory effect on platelet COX-1 channel was significantly weaker than that of aspirin 100 mg QD. In view of this, this study intends to investigate the antiplatelet effect of indobufen 200 mg Bid in patients with coronary atherosclerosis by comparing it with conventional-dose aspirin 100 mg QD.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | March 20, 2022 |
Est. primary completion date | March 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Clinical diagnosis of coronary atherosclerosis without indications for stent implantation. 2. Age = 18 years, = 65 years 3. Sign informed consent Exclusion Criteria: 1. A history of asthma or allergic constitution or known allergy to indobufen or aspirin. 2. High risk of bleeding (low hemoglobin 10g / L, history of peptic ulcer disease, fecal occult blood positive or known active bleeding, history of cerebral hemorrhage within 6 months, history of fundus hemorrhage, etc). 3. Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value. 4. History of smoking and alcoholism. 5. History of diabetes. 6. Pregnancy and lactation women. 7. Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required. 8. Any other reason may affect the results of this study. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MPA | Maximum platelet aggregation induced by arachidonic acid | Within 24 hours after one month of medication | |
Primary | TXB2 | Plasma thromboxaneB2 | Within 1 month after one month of medication | |
Primary | 11-dh-TXB2 | Urine 11-dehydro thromboxaneB2 | Within 1 month after one month of medication | |
Secondary | Adverse Events | Monitor the bleeding events of subjects during the trial | Within 1 month after the first medication |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02335086 -
DNA Damage & Repair Proteins In Patients With Atherosclerotic Coronary Artery Disease
|
N/A | |
Withdrawn |
NCT02265146 -
ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study
|
||
Completed |
NCT00811772 -
Trial of Drug Eluting Stent Versus Bare Metal Stent to Treat Coronary Artery Stenosis
|
N/A | |
Recruiting |
NCT03322332 -
Adipokines of Epicardial Adipose Tissue and Atherosclerosis of Coronary Arteries
|
N/A | |
Completed |
NCT02305953 -
Cytokines and Vascular Inflammation in Psoriasis
|
N/A | |
Completed |
NCT01642173 -
Assessment of Coronary Plaque Composition Using Optical Coherence Tomography
|
Phase 1 | |
Completed |
NCT02316782 -
Bifurcation Lesion Analysis and STenting / BLAST
|
||
Completed |
NCT00548613 -
Combination Stem Cell (MESENDO) Therapy for Utilization and Rescue of Infarcted Myocardium
|
Phase 1 | |
Terminated |
NCT00243308 -
Serp-1 for the Treatment of Acute Coronary Syndrome
|
Phase 2 | |
Completed |
NCT01722214 -
Trial on the Effect of Adalimumab on Vascular Inflammation in Patients With Psoriasis
|
Phase 4 | |
Terminated |
NCT01030328 -
AFRICA: Atorvastatin Plus Fenofibric Acid (TriLipix) in the Reduction of Intermediate Coronary Atherosclerosis
|
Phase 3 | |
Suspended |
NCT00790764 -
Phase II Combination Stem Cell Therapy for the Treatment of Severe Coronary Ischemia(CI)
|
Phase 2 | |
Active, not recruiting |
NCT01061398 -
CT-FIRST: Cardiac Computed Tomography Versus Stress Imaging For Initial Risk STratification
|
N/A | |
Completed |
NCT00431717 -
Coronary Computed Tomography Angiography and SPECT in Asymptomatic Diabetes
|
N/A | |
Completed |
NCT00431977 -
Validation Study of Coronary CT Angiography as a Screening Tool in Asymptomatic Diabetes
|
N/A | |
Recruiting |
NCT00155350 -
Treatment of Coronary Atherosclerosis by Insulin Sensitizers in Insulin-Resistant Patients
|
Phase 4 | |
Recruiting |
NCT05708547 -
Role of Mitophagy in Myeloid Cells During Coronary Atherosclerosis.
|
||
Terminated |
NCT02440646 -
Natural History of Coronary Atherosclerosis in Real-World Stable Chest Pain Patients Underwent Computed Tomography Angiography in Comparison With Invasive Multimodality Imaging
|
||
Completed |
NCT02576704 -
Prognostic Value of Myocardial Perfusion Heterogeneity in Normal SPECT Studies
|
N/A | |
Terminated |
NCT01268319 -
CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
|
N/A |