Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 66 of 92 for:    ASPIRIN AND thromboxane

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308551
Recruitment Status : Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Henan Institute of Cardiovascular Epidemiology

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.

Condition or disease Intervention/treatment Phase
Stable Coronary Heart Disease Drug: Indobufen Drug: Aspirin Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 594 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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).
Primary Purpose: Other
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
Estimated Study Start Date : March 16, 2020
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 20, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Indobufen
200 mg Indobufen, bid po, 90 days
Drug: Indobufen
Indobufen Tablets

Active Comparator: Aspirin
100 mg Aspirin, qd po, 90 days
Drug: Aspirin
Aspirin Tablets




Primary Outcome Measures :
  1. Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin [ Time Frame: 7 days ]
    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.

  2. Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin [ Time Frame: 30 days ]
    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.

  3. Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin [ Time Frame: 90 days ]
    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.

  4. Concentration of Thromboxane B2 (TXB2) at baseline [ Time Frame: 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)

  5. Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin [ Time Frame: 7 days ]
    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)

  6. Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin [ Time Frame: 30 days ]
    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)

  7. Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin [ Time Frame: 90 days ]
    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 :
  1. Incidence of Bleeding [ Time Frame: baseline, 7, 30 and 90 days ]
    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)

  2. Incidence of Adverse Gastrointestinal reaction [ Time Frame: 7, 30 and 90 days ]
    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

  3. Blood concentration [ Time Frame: 7, 30 and 90 days ]
    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.

  4. Cyclooxygenase-1 gene phenotype [ Time Frame: baseline ]
    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.

  5. Major adverse cardiovascular events [ Time Frame: 7, 30 and 90 days ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years < age ≤ 85 years;
  2. 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.

  3. Willing to sign the informed consent.

Exclusion Criteria:

  1. Acute coronary syndrome (ACS) occurred within 3 months before screening;
  2. Percutaneous coronary intervention or CABG surgery within 9 months before screening;
  3. Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
  4. In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
  5. Congestive heart failure or left ventricular ejection fraction <35%;
  6. A positive history of Chronic Obstructive Pulmonary Disease (COPD);
  7. bleeding tendency or severe lung disease;
  8. Active pathological bleeding;
  9. History of intracranial hemorrhage (less than 3 months);
  10. Allergic to indobufen / aspirin (or any of its ingredients);
  11. Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
  12. Pregnancy, lactation and those who have a birth plan;
  13. Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;
  14. Have a history of drug or alcohol abuse in the past 2 years;
  15. Use of non-steroidal anti-inflammatory drugs (within 3 months);
  16. Creatinine clearance <30ml/min;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308551


Contacts
Layout table for location contacts
Contact: junhui zhang, MD +86 0371-58681033 09junhuizhang@163.com

Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
Layout table for investigator information
Principal Investigator: chuanyu gao, MD central china fuwai hospital

Layout table for additonal information
Responsible Party: Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier: NCT04308551    
Other Study ID Numbers: HenanICE202001
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Indobufen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics