NCT03230851

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Atherosclerosis

Interventions

Type	Name	Description
DRUG	aspirin 100mg/d therapy	100mg aspirin for at least 5 days followed by aspirin 100mg/d
DRUG	aspirin 100mg/2d therapy	100mg aspirin for at least 5 days followed by aspirin 100mg/2d
DRUG	aspirin 100mg/3d therapy	100mg aspirin for at least 5 days followed by aspirin 100mg/3d
DRUG	aspirin 50mg bid therapy	100mg aspirin for at least 5 days followed by aspirin 50mg bid
DRUG	aspirin 75mg/d therapy	100mg aspirin for at least 5 days followed by aspirin 75mg/d
DRUG	aspirin 50mg/d therapy	100mg aspirin for at least 5 days followed by aspirin 50mg/d
DRUG	indobufen 100mg bid therapy	100mg aspirin for at least 5 days followed by indobufen 100mg bid

Timeline

• Start date: 2017-08-20
• Primary completion: 2018-07-10
• Completion: 2018-08-10
• First posted: 2017-07-27
• Last updated: 2017-07-31

Locations

1 site across 1 country: China