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

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ClinicalTrials.gov Identifier: NCT03230851
Recruitment Status : Unknown
Verified July 2017 by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : July 27, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE July 24, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date July 31, 2017
Estimated Study Start Date  ICMJE August 20, 2017
Estimated Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
  • platelet aggregation [ Time Frame: 2 hours ]
    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 [ Time Frame: 3montshs ]
    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 [ Time Frame: 3 months ]
    The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
  • platelet aggregation [ Time Frame: 2 hours ]
    Regional differences between blood sampls 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 [ Time Frame: 3montshs ]
    The plasma thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
  • urine 11-dehydro thromboxaneB2 [ Time Frame: 3 months ]
    The urine 11-dehydro thromboxane B2 concentration of each subjects are measured byELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
Change History Complete list of historical versions of study NCT03230851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Official Title  ICMJE the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Coronary Atherosclerosis
Intervention  ICMJE
  • Drug: aspirin 100mg/d therapy
    100mg aspirin for at least 5 days followed by aspirin 100mg/d
  • Drug: aspirin 100mg/2d therapy
    100mg aspirin for at least 5 days followed by aspirin 100mg/2d
  • Drug: aspirin 100mg/3d therapy
    100mg aspirin for at least 5 days followed by aspirin 100mg/3d
  • Drug: aspirin 50mg bid therapy
    100mg aspirin for at least 5 days followed by aspirin 50mg bid
  • Drug: aspirin 75mg/d therapy
    100mg aspirin for at least 5 days followed by aspirin 75mg/d
  • Drug: aspirin 50mg/d therapy
    100mg aspirin for at least 5 days followed by aspirin 50mg/d
  • Drug: indobufen 100mg bid therapy
    100mg aspirin for at least 5 days followed by indobufen 100mg bid
Study Arms  ICMJE
  • Experimental: aspirin 100mg/d therapy
    Group1: aspirin 100 mg/d;
    Intervention: Drug: aspirin 100mg/d therapy
  • Experimental: aspirin 100mg/2d therapy
    Group2: aspirin ;
    Intervention: Drug: aspirin 100mg/2d therapy
  • Experimental: aspirin 100mg/3d therapy
    Groups3: aspirin ;
    Intervention: Drug: aspirin 100mg/3d therapy
  • Experimental: aspirin 50mg bid therapy
    Groups4: morning 50mg evening 50mg;
    Intervention: Drug: aspirin 50mg bid therapy
  • Experimental: aspirin 75mg/d therapy
    Group5: aspirin 75mg / d;
    Intervention: Drug: aspirin 75mg/d therapy
  • Experimental: aspirin 50mg/d therapy
    Group6: aspirin 50mg / d;
    Intervention: Drug: aspirin 50mg/d therapy
  • Experimental: indobufen 100mg bid therapy
    Group7: 100mg bid
    Intervention: Drug: indobufen 100mg bid therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
210
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 10, 2018
Estimated Primary Completion Date July 10, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03230851
Other Study ID Numbers  ICMJE 006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chunjian Li, The First Affiliated Hospital with Nanjing Medical University
Study Sponsor  ICMJE The First Affiliated Hospital with Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The First Affiliated Hospital with Nanjing Medical University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP