- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230851
the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Li Chunjian, Ph.D
- Phone Number: 6018 +86-25-83718836
- Email: lijay@njmu.edu.cn
Study Contact Backup
- Name: Mei Lianlian
- Phone Number: 17766092046
- Email: Maylianlian1989@163.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210029
- First Affiliated Hospital of Nanjing Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .
Patient aged >18 years and ≤75years. Must be able to swallow tablets
Exclusion Criteria:
Aspirin resistance; uncontrolled hypertension (> 160 / 100mmHg); hemoglobin <100g / L; hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history; coronary artery bypass surgery; cardiac function grade Ⅳ.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: aspirin 100mg/d therapy
Group1: aspirin 100 mg/d;
|
100mg aspirin for at least 5 days followed by aspirin 100mg/d
|
EXPERIMENTAL: aspirin 100mg/2d therapy
Group2: aspirin ;
|
100mg aspirin for at least 5 days followed by aspirin 100mg/2d
|
EXPERIMENTAL: aspirin 100mg/3d therapy
Groups3: aspirin ;
|
100mg aspirin for at least 5 days followed by aspirin 100mg/3d
|
EXPERIMENTAL: aspirin 50mg bid therapy
Groups4: morning 50mg evening 50mg;
|
100mg aspirin for at least 5 days followed by aspirin 50mg bid
|
EXPERIMENTAL: aspirin 75mg/d therapy
Group5: aspirin 75mg / d;
|
100mg aspirin for at least 5 days followed by aspirin 75mg/d
|
EXPERIMENTAL: aspirin 50mg/d therapy
Group6: aspirin 50mg / d;
|
100mg aspirin for at least 5 days followed by aspirin 50mg/d
|
EXPERIMENTAL: indobufen 100mg bid therapy
Group7: 100mg bid
|
100mg aspirin for at least 5 days followed by indobufen 100mg bid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
platelet aggregation
Time Frame: 2 hours
|
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
|
2 hours
|
plasma thromboxaneB2
Time Frame: 3montshs
|
The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman
chemical, thromboxaneB2 express EIA kit-Monoclonal)
|
3montshs
|
urine 11-dehydro thromboxaneB2
Time Frame: 3 months
|
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman
chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Aspirin
- Indobufen
Other Study ID Numbers
- 006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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