drugset / Trial / NCT03230851

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

NCT03230851

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-08-20
Primary completion
2018-07-10
Completion
2018-08-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 50 mg
Subject Aspirin Small molecule 75 mg
Subject Aspirin Small molecule 100 mg
Subject Indobufen Small molecule 100 mg