the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
1 other identifier
interventional
210
1 country
1
Brief Summary
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2017
CompletedFirst Posted
Study publicly available on registry
July 27, 2017
CompletedStudy Start
First participant enrolled
August 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2018
CompletedJuly 31, 2017
July 1, 2017
11 months
July 24, 2017
July 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
platelet aggregation
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
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
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
3 months
Study Arms (7)
aspirin 100mg/d therapy
EXPERIMENTALGroup1: aspirin 100 mg/d;
aspirin 100mg/2d therapy
EXPERIMENTALGroup2: aspirin ;
aspirin 100mg/3d therapy
EXPERIMENTALGroups3: aspirin ;
aspirin 50mg bid therapy
EXPERIMENTALGroups4: morning 50mg evening 50mg;
aspirin 75mg/d therapy
EXPERIMENTALGroup5: aspirin 75mg / d;
aspirin 50mg/d therapy
EXPERIMENTALGroup6: aspirin 50mg / d;
indobufen 100mg bid therapy
EXPERIMENTALGroup7: 100mg bid
Interventions
100mg aspirin for at least 5 days followed by aspirin 100mg/d
100mg aspirin for at least 5 days followed by aspirin 100mg/2d
100mg aspirin for at least 5 days followed by aspirin 100mg/3d
100mg aspirin for at least 5 days followed by aspirin 50mg bid
100mg aspirin for at least 5 days followed by aspirin 75mg/d
100mg aspirin for at least 5 days followed by aspirin 50mg/d
100mg aspirin for at least 5 days followed by indobufen 100mg bid
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .
- Patient aged \>18 years and ≤75years. Must be able to swallow tablets
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 24, 2017
First Posted
July 27, 2017
Study Start
August 20, 2017
Primary Completion
July 10, 2018
Study Completion
August 10, 2018
Last Updated
July 31, 2017
Record last verified: 2017-07