the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy

Phase 4

• Conditions: Coronary Atherosclerosis
• Interventions: Drug: aspirin 100mg/d therapy; Drug: aspirin 100mg/2d therapy; Drug: aspirin 100mg/3d therapy; Drug: aspirin 50mg bid therapy; Drug: aspirin 75mg/d therapy; Drug: aspirin 50mg/d therapy; Drug: indobufen 100mg bid therapy

• Registration Number: NCT03230851
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (\> 160 / 100mmHg),hemoglobin concentration \<100g /L, hemorrhagic disease or a history of bleeding tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor, active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA 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 1month,6months and1 year. The stomach Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are recorded.

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-24
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-27
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31
• Study Start: 2017-08-20
• Primary Completion: 2018-07-10
• Study Completion: 2018-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin 100mg/d therapy	aspirin 100mg/d therapy	Group1: aspirin 100 mg/d;
aspirin 100mg/2d therapy	aspirin 100mg/2d therapy	Group2: aspirin ;
aspirin 100mg/3d therapy	aspirin 100mg/3d therapy	Groups3: aspirin ;
aspirin 50mg bid therapy	aspirin 50mg bid therapy	Groups4: morning 50mg evening 50mg;
aspirin 75mg/d therapy	aspirin 75mg/d therapy	Group5: aspirin 75mg / d;
aspirin 50mg/d therapy	aspirin 50mg/d therapy	Group6: aspirin 50mg / d;
indobufen 100mg bid therapy	indobufen 100mg bid therapy	Group7: 100mg bid

Primary Outcome Measures

Name	Time	Method
platelet aggregation	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).
plasma thromboxaneB2	3montshs	The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
urine 11-dehydro thromboxaneB2	3 months	The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)

Trial Locations

Locations (1)

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China