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

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. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Atherosclerosis Drug: aspirin 100mg/d therapy Drug: aspirin 100mg/2d therapy Drug: aspirin 100mg/3d therapy Drug: aspirin 50mg bid therapy Drug: aspirin 75mg/d therapy Drug: aspirin 50mg/d therapy Drug: indobufen 100mg bid therapy Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Estimated Study Start Date : August 20, 2017
Estimated Primary Completion Date : July 10, 2018
Estimated Study Completion Date : August 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: aspirin 100mg/d therapy
Group1: aspirin 100 mg/d;
 Drug: aspirin 100mg/d therapy
100mg aspirin for at least 5 days followed by aspirin 100mg/d
Experimental: aspirin 100mg/2d therapy
Group2: aspirin ;
 Drug: aspirin 100mg/2d therapy
100mg aspirin for at least 5 days followed by aspirin 100mg/2d
Experimental: aspirin 100mg/3d therapy
Groups3: aspirin ;
 Drug: aspirin 100mg/3d therapy
100mg aspirin for at least 5 days followed by aspirin 100mg/3d
Experimental: aspirin 50mg bid therapy
Groups4: morning 50mg evening 50mg;
 Drug: aspirin 50mg bid therapy
100mg aspirin for at least 5 days followed by aspirin 50mg bid
Experimental: aspirin 75mg/d therapy
Group5: aspirin 75mg / d;
 Drug: aspirin 75mg/d therapy
100mg aspirin for at least 5 days followed by aspirin 75mg/d
Experimental: aspirin 50mg/d therapy
Group6: aspirin 50mg / d;
 Drug: aspirin 50mg/d therapy
100mg aspirin for at least 5 days followed by aspirin 50mg/d
Experimental: indobufen 100mg bid therapy
Group7: 100mg bid
 Drug: indobufen 100mg bid therapy
100mg aspirin for at least 5 days followed by indobufen 100mg bid


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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)

  3. 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)


Eligibility Criteria
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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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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): NCT03230851


Contacts
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Contact: Li Chunjian, Ph.D +86-25-83718836 ext 6018 lijay@njmu.edu.cn
Contact: Mei Lianlian 17766092046 Maylianlian1989@163.com

Locations
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China, Jiangsu
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
More Information
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Responsible Party: Chunjian Li, professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03230851    
Other Study ID Numbers: 006
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017

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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
Keywords provided by Chunjian Li, The First Affiliated Hospital with Nanjing Medical University:
Light Transmittance Aggregometry
Indobufen
Aspirin
Plasma Thromboxane
Urine 11-dehydro thromboxane
Additional relevant MeSH terms:
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Atherosclerosis
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Aspirin
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