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

N

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

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

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

Trial contacts and locations

1

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Central trial contact

Li Chunjian, Ph.D; Mei Lianlian

Data sourced from clinicaltrials.gov

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