An interventional study of Indobufen and Aspirin in Stable Coronary Heart Disease, sponsored by Henan Institute of Cardiovascular Epidemiology. Withdrawn. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Henan Institute of Cardiovascular Epidemiology · Not applicable, Interventional, and Other
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable coronary heart disease.
Henan Institute of Cardiovascular Epidemiology is the lead sponsor of 31 studies on the registry; 12 are open to participants now.
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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.
Exclusion Criteria:
200 mg Indobufen, bid po, 90 days
Drug: Indobufen
100 mg Aspirin, qd po, 90 days
Drug: Aspirin
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: baseline
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)
Time frame: 7 days
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)
Time frame: 30 days
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)
Time frame: 90 days
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)
Time frame: baseline, 7, 30 and 90 days
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
Time frame: 7, 30 and 90 days
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.
Time frame: 7, 30 and 90 days
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.
Time frame: baseline
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
Time frame: 7, 30 and 90 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Dec 2026, 24 months later.
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This study is withdrawn, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indobufen
Henan Institute of Cardiovascular Epidemiology