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

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.

Conditions

• Coronary Atherosclerosis

Interventions

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-20

Primary Completion

2018-07-10

Completion

2018-08-10

Countries

• China

Study Locations