Clinical trial NCT03230851: the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Official title: the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Atherosclerosis
Keywords: Light Transmittance Aggregometry
Indobufen
Aspirin
Plasma Thromboxane
Urine 11-dehydro thromboxane
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: platelet aggregation
timeFrame: 2 hours
measure: plasma thromboxaneB2
timeFrame: 3montshs
measure: urine 11-dehydro thromboxaneB2
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: