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

Primary Purpose

Coronary Atherosclerosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
aspirin 100mg/d therapy
aspirin 100mg/2d therapy
aspirin 100mg/3d therapy
aspirin 50mg bid therapy
aspirin 75mg/d therapy
aspirin 50mg/d therapy
indobufen 100mg bid therapy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Atherosclerosis focused on measuring Light Transmittance Aggregometry, Indobufen, Aspirin, Plasma Thromboxane, Urine 11-dehydro thromboxane

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital of Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

aspirin 100mg/d therapy

aspirin 100mg/2d therapy

aspirin 100mg/3d therapy

aspirin 50mg bid therapy

aspirin 75mg/d therapy

aspirin 50mg/d therapy

indobufen 100mg bid therapy

Arm Description

Group1: aspirin 100 mg/d;

Group2: aspirin ;

Groups3: aspirin ;

Groups4: morning 50mg evening 50mg;

Group5: aspirin 75mg / d;

Group6: aspirin 50mg / d;

Group7: 100mg bid

Outcomes

Primary Outcome Measures

platelet aggregation
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
plasma thromboxaneB2
The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
urine 11-dehydro thromboxaneB2
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)

Secondary Outcome Measures

Full Information

First Posted
July 24, 2017
Last Updated
July 27, 2017
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03230851
Brief Title
the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Official Title
the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Anticipated)
Primary Completion Date
July 10, 2018 (Anticipated)
Study Completion Date
August 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis
Keywords
Light Transmittance Aggregometry, Indobufen, Aspirin, Plasma Thromboxane, Urine 11-dehydro thromboxane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aspirin 100mg/d therapy
Arm Type
Experimental
Arm Description
Group1: aspirin 100 mg/d;
Arm Title
aspirin 100mg/2d therapy
Arm Type
Experimental
Arm Description
Group2: aspirin ;
Arm Title
aspirin 100mg/3d therapy
Arm Type
Experimental
Arm Description
Groups3: aspirin ;
Arm Title
aspirin 50mg bid therapy
Arm Type
Experimental
Arm Description
Groups4: morning 50mg evening 50mg;
Arm Title
aspirin 75mg/d therapy
Arm Type
Experimental
Arm Description
Group5: aspirin 75mg / d;
Arm Title
aspirin 50mg/d therapy
Arm Type
Experimental
Arm Description
Group6: aspirin 50mg / d;
Arm Title
indobufen 100mg bid therapy
Arm Type
Experimental
Arm Description
Group7: 100mg bid
Intervention Type
Drug
Intervention Name(s)
aspirin 100mg/d therapy
Intervention Description
100mg aspirin for at least 5 days followed by aspirin 100mg/d
Intervention Type
Drug
Intervention Name(s)
aspirin 100mg/2d therapy
Intervention Description
100mg aspirin for at least 5 days followed by aspirin 100mg/2d
Intervention Type
Drug
Intervention Name(s)
aspirin 100mg/3d therapy
Intervention Description
100mg aspirin for at least 5 days followed by aspirin 100mg/3d
Intervention Type
Drug
Intervention Name(s)
aspirin 50mg bid therapy
Intervention Description
100mg aspirin for at least 5 days followed by aspirin 50mg bid
Intervention Type
Drug
Intervention Name(s)
aspirin 75mg/d therapy
Intervention Description
100mg aspirin for at least 5 days followed by aspirin 75mg/d
Intervention Type
Drug
Intervention Name(s)
aspirin 50mg/d therapy
Intervention Description
100mg aspirin for at least 5 days followed by aspirin 50mg/d
Intervention Type
Drug
Intervention Name(s)
indobufen 100mg bid therapy
Intervention Description
100mg aspirin for at least 5 days followed by indobufen 100mg bid
Primary Outcome Measure Information:
Title
platelet aggregation
Description
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
Time Frame
2 hours
Title
plasma thromboxaneB2
Description
The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
Time Frame
3montshs
Title
urine 11-dehydro thromboxaneB2
Description
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chunjian, Ph.D
Phone
+86-25-83718836
Ext
6018
Email
lijay@njmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Mei Lianlian
Phone
17766092046
Email
Maylianlian1989@163.com
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

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

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