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

Nanjing Medical University

Status and phase: Unknown; Phase 4

Conditions: Coronary Atherosclerosis

Treatments: Drug: aspirin 50mg bid therapy; Drug: aspirin 50mg/d therapy; Drug: aspirin 100mg/2d therapy; Drug: aspirin 100mg/d therapy; Drug: aspirin 100mg/3d therapy; Drug: aspirin 75mg/d therapy; Drug: indobufen 100mg bid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03230851

006

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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210 participants in 7 patient groups

aspirin 100mg/d therapy

Experimental group

Description:

Group1: aspirin 100 mg/d;

Treatment:

Drug: aspirin 100mg/d therapy

aspirin 100mg/2d therapy

Experimental group

Description:

Group2: aspirin ;

Treatment:

Drug: aspirin 100mg/2d therapy

aspirin 100mg/3d therapy

Experimental group

Description:

Groups3: aspirin ;

Treatment:

Drug: aspirin 100mg/3d therapy

aspirin 50mg bid therapy

Experimental group

Description:

Groups4: morning 50mg evening 50mg;

Treatment:

Drug: aspirin 50mg bid therapy

aspirin 75mg/d therapy

Experimental group

Description:

Group5: aspirin 75mg / d;

Treatment:

Drug: aspirin 75mg/d therapy

aspirin 50mg/d therapy

Experimental group

Description:

Group6: aspirin 50mg / d;

Treatment:

Drug: aspirin 50mg/d therapy

indobufen 100mg bid therapy

Experimental group

Description:

Group7: 100mg bid

Treatment:

Drug: indobufen 100mg bid therapy