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

NCT ID: NCT03230851

Last Updated: 2017-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2018-08-10

Brief Summary

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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

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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

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Coronary Atherosclerosis

Keywords

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Light Transmittance Aggregometry Indobufen Aspirin Plasma Thromboxane Urine 11-dehydro thromboxane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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aspirin 100mg/d therapy

Group1: aspirin 100 mg/d;

Group Type EXPERIMENTAL

aspirin 100mg/d therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by aspirin 100mg/d

aspirin 100mg/2d therapy

Group2: aspirin ;

Group Type EXPERIMENTAL

aspirin 100mg/2d therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by aspirin 100mg/2d

aspirin 100mg/3d therapy

Groups3: aspirin ;

Group Type EXPERIMENTAL

aspirin 100mg/3d therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by aspirin 100mg/3d

aspirin 50mg bid therapy

Groups4: morning 50mg evening 50mg;

Group Type EXPERIMENTAL

aspirin 50mg bid therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by aspirin 50mg bid

aspirin 75mg/d therapy

Group5: aspirin 75mg / d;

Group Type EXPERIMENTAL

aspirin 75mg/d therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by aspirin 75mg/d

aspirin 50mg/d therapy

Group6: aspirin 50mg / d;

Group Type EXPERIMENTAL

aspirin 50mg/d therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by aspirin 50mg/d

indobufen 100mg bid therapy

Group7: 100mg bid

Group Type EXPERIMENTAL

indobufen 100mg bid therapy

Intervention Type DRUG

100mg aspirin for at least 5 days followed by indobufen 100mg bid

Interventions

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aspirin 100mg/d therapy

100mg aspirin for at least 5 days followed by aspirin 100mg/d

Intervention Type DRUG

aspirin 100mg/2d therapy

100mg aspirin for at least 5 days followed by aspirin 100mg/2d

Intervention Type DRUG

aspirin 100mg/3d therapy

100mg aspirin for at least 5 days followed by aspirin 100mg/3d

Intervention Type DRUG

aspirin 50mg bid therapy

100mg aspirin for at least 5 days followed by aspirin 50mg bid

Intervention Type DRUG

aspirin 75mg/d therapy

100mg aspirin for at least 5 days followed by aspirin 75mg/d

Intervention Type DRUG

aspirin 50mg/d therapy

100mg aspirin for at least 5 days followed by aspirin 50mg/d

Intervention Type DRUG

indobufen 100mg bid therapy

100mg aspirin for at least 5 days followed by indobufen 100mg bid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chunjian Li

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Li Chunjian, Ph.D

Role: CONTACT

Phone: +86-25-83718836

Email: [email protected]

Mei Lianlian

Role: CONTACT

Phone: 17766092046

Email: [email protected]

Other Identifiers

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006

Identifier Type: -

Identifier Source: org_study_id