Back to resultsEffect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease
Primary Purpose
Stable Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Indobufen
Aspirin
Sponsored by
About this trial
This is an interventional other trial for Stable Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- 18 years < age ≤ 85 years;
Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;
2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
- Willing to sign the informed consent.
Exclusion Criteria:
- Acute coronary syndrome (ACS) occurred within 3 months before screening;
- Percutaneous coronary intervention or CABG surgery within 9 months before screening;
- Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
- In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
- Congestive heart failure or left ventricular ejection fraction <35%;
- A positive history of Chronic Obstructive Pulmonary Disease (COPD);
- bleeding tendency or severe lung disease;
- Active pathological bleeding;
- History of intracranial hemorrhage (less than 3 months);
- Allergic to indobufen / aspirin (or any of its ingredients);
- Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
- Pregnancy, lactation and those who have a birth plan;
- Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;
- Have a history of drug or alcohol abuse in the past 2 years;
- Use of non-steroidal anti-inflammatory drugs (within 3 months);
- Creatinine clearance <30ml/min;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Indobufen
Aspirin
Arm Description
200 mg Indobufen, bid po, 90 days
100 mg Aspirin, qd po, 90 days
Outcomes
Primary Outcome Measures
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 7 days.
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 30 days.
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 90 days.
Concentration of Thromboxane B2 (TXB2) at baseline
The fasting blood was collected after the subjects signed informed consent；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin
The fasting blood was collected 7 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin
The fasting blood was collected 30 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin
The fasting blood was collected 90 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Secondary Outcome Measures
Incidence of Bleeding
During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced bleeding (the extent and location of the bleeding) and the degree of bleeding related to indobufen or aspirin (Certainly, likely, possible, suspicious, impossible)
Incidence of Adverse Gastrointestinal reaction
During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced adverse gastrointestinal reaction, such as nausea, vomiting, upper abdominal discomfort or pain, gastric mucosal damage, gastric ulcers and bleeding, etc
Blood concentration
The fasting blood was collected on the day of 7 days, 30 days, and 90 days；And the blood concentration of aspirin or indobufen or clopidogrel or ticagrelor was detected.
Cyclooxygenase-1 gene phenotype
The fasting blood was collected and saved on the day of enrollment, and then the gene phenotype of cyclooxygenase-1 would be detected, and their relationship with platelet aggregation also would be analyzed.
Major adverse cardiovascular events
Number of angina pectoris symptoms, non ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI), stroke, cardiovascular death, cerebrovascular death, all-cause death
Full Information
NCT ID
NCT04308551
First Posted
March 6, 2020
Last Updated
February 4, 2021
Sponsor
Henan Institute of Cardiovascular Epidemiology
1. Study Identification
Unique Protocol Identification Number
NCT04308551
Brief Title
Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease
Official Title
Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Stable Coronary Heart Disease. A Prospective, Randomized and Controlled，Single Blind, Single-center, Opening Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2021 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Heart Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The treatment in this study was open. Optical density turbidimetric platelet aggregation (LTA) and thromboelastography (TEG) were used to detect the platelet aggregation rate induced by AA and ADP, and the metabolites were measured by ELISA. All were done by the laboratory personnel, and they were unaware of the setting of treatment medication (blind method).
Allocation
Randomized
Enrollment
594 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Indobufen
Arm Type
Experimental
Arm Description
200 mg Indobufen, bid po, 90 days
Arm Title
Aspirin
Arm Type
Active Comparator
Arm Description
100 mg Aspirin, qd po, 90 days
Intervention Type
Drug
Intervention Name(s)
Indobufen
Intervention Description
Indobufen Tablets
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Aspirin Tablets
Primary Outcome Measure Information:
Title
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin
Description
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 7 days.
Time Frame
7 days
Title
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
Description
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 30 days.
Time Frame
30 days
Title
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin
Description
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 90 days.
Time Frame
90 days
Title
Concentration of Thromboxane B2 (TXB2) at baseline
Description
The fasting blood was collected after the subjects signed informed consent；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Time Frame
baseline
Title
Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin
Description
The fasting blood was collected 7 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Time Frame
7 days
Title
Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin
Description
The fasting blood was collected 30 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Time Frame
30 days
Title
Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin
Description
The fasting blood was collected 90 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Incidence of Bleeding
Description
During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced bleeding (the extent and location of the bleeding) and the degree of bleeding related to indobufen or aspirin (Certainly, likely, possible, suspicious, impossible)
Time Frame
baseline, 7, 30 and 90 days
Title
Incidence of Adverse Gastrointestinal reaction
Description
During the study period, we used dual occult blood and questionnaire format to assess whether the subject experienced adverse gastrointestinal reaction, such as nausea, vomiting, upper abdominal discomfort or pain, gastric mucosal damage, gastric ulcers and bleeding, etc
Time Frame
7, 30 and 90 days
Title
Blood concentration
Description
The fasting blood was collected on the day of 7 days, 30 days, and 90 days；And the blood concentration of aspirin or indobufen or clopidogrel or ticagrelor was detected.
Time Frame
7, 30 and 90 days
Title
Cyclooxygenase-1 gene phenotype
Description
The fasting blood was collected and saved on the day of enrollment, and then the gene phenotype of cyclooxygenase-1 would be detected, and their relationship with platelet aggregation also would be analyzed.
Time Frame
baseline
Title
Major adverse cardiovascular events
Description
Number of angina pectoris symptoms, non ST-segment elevation myocardial infarction (NSTEMI), ST-segment elevation myocardial infarction (STEMI), stroke, cardiovascular death, cerebrovascular death, all-cause death
Time Frame
7, 30 and 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years < age ≤ 85 years;
Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;
2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
Willing to sign the informed consent.
Exclusion Criteria:
Acute coronary syndrome (ACS) occurred within 3 months before screening;
Percutaneous coronary intervention or CABG surgery within 9 months before screening;
Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
Congestive heart failure or left ventricular ejection fraction <35%;
A positive history of Chronic Obstructive Pulmonary Disease (COPD);
bleeding tendency or severe lung disease;
Active pathological bleeding;
History of intracranial hemorrhage (less than 3 months);
Allergic to indobufen / aspirin (or any of its ingredients);
Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
Pregnancy, lactation and those who have a birth plan;
Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;
Have a history of drug or alcohol abuse in the past 2 years;
Use of non-steroidal anti-inflammatory drugs (within 3 months);
Creatinine clearance <30ml/min;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
junhui zhang, MD
Phone
+86 0371-58681033
Email
09junhuizhang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chuanyu gao, MD
Organizational Affiliation
central china fuwai hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease
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