Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Coronary Heart Disease

NCT04308551 | Withdrawn

• 1 other identifier: HenanICE202001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stable Coronary Heart Disease

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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)

  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)

  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)

  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)

  90 days

Secondary Outcomes (5)

• Incidence of Bleeding

  baseline, 7, 30 and 90 days

• Incidence of Adverse Gastrointestinal reaction

  7, 30 and 90 days

• Blood concentration

  7, 30 and 90 days

• Cyclooxygenase-1 gene phenotype

  baseline

• Major adverse cardiovascular events

  7, 30 and 90 days

Study Arms (2)

Indobufen

EXPERIMENTAL

200 mg Indobufen, bid po, 90 days

Drug: Indobufen

Aspirin

ACTIVE COMPARATOR

100 mg Aspirin, qd po, 90 days

Drug: Aspirin

Interventions

Indobufen DRUG

Indobufen Tablets

Indobufen

Aspirin DRUG

Aspirin Tablets

Aspirin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years \< age ≤ 85 years;
• Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
• 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;
• 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.
• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

MeSH Terms

Interventions

indobufen; Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• chuanyu gao, MD

  central china fuwai hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2020
• First Posted: March 16, 2020
• Study Start: December 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share