acute coronary syndromes
Conditions
Interventions
Patients with acute coronary syndrome:Taking loading dose(180mg) Ticagrelor before PCI and maintenance dose 90mg Bid
Sponsors
Institute of Clinical Pharmacology, Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Healthy volunteers: 1. Healthy male subjects (aged 18-45 years) based on medical history, physical examination, electrocardiogram, and clinical laboratory test results; 2. Weight should be greater than 50 kg and BBMI in range of 19~24kg/m2 [BMI=weight (kg)/height 2(m2)], including boundary value. Great disparity is not allowed in the weight of subjects in the same batch; 3. Subject should have a strong understand of the object, nature and eventuality of trial, volunteer for the trial and sign the informed consent; 4. Subject is able to communicate with investigator well and comply with requires of study. Patients with acute coronary syndrome: 1. diagnosed with acute coronary syndrome (medium to high risk) and schduled for primary PCI; 2. received combined therapy with aspirin and clopidogrel at least for 12 months after PCI; 3. male or non pregnant women aged 18-80 years old; 4. signed informed consent and agree to follow the requirements of study.
Exclusion criteria
Exclusion criteria: Healthy volunteers: 1. Specific allergic history (asthma, measles, eczema et.al); Allergic constitution: The persons allergy for investigator product, food, pollen or ingredients of investigator product (analogue); 2. Laboratory test (hematology, urine analysis, blood biochemistry) results 2 weeks before trial judged as clinical significance of abnormal; 3. Any history of severe disease or medical history of cardiovascular system, endocrine system, nervous system, lung, hematology, immunology, pathergasiology and metabolic disturbance; 4. Physical examination and 12-lead electrocardiogram results before trial judged as clinical significance of abnormal; 5. HIV, HBV, HCV, TP-Anti positive; 6. Suffering clinical severe disease or surgery 4 weeks before trial; 7. Participate other clinical trial in the last 3 months; 8. Blood donation in the last 3 month or intend to donate blood in the following 1 month; 9. Used any medicine in the last 2 weeks; 10. Frequently drinking 6 months before trial, averagely get above 14 units alcohol every week (1 unit=beer 360mL or 40% liquor 45mL or wine 150mL); 11. Taking the soft drugs (ecstasy, Ken powder, MaGu et.al) 3 months before trial or hard drugs (cocaine, heroin, meth et.al) 1 year before trial; 12. Averagely take above 1 cigarette a day at the last 3 months; 13. Special requirements for food, refuse to comply with unified diet; 14. Drinking too much tea, coffee or/and drinking with caffeine (averagely 200mL *8 cups a day); 15. Gestation period and lactation period women, menstrual period conflict with trial; 16. The machine operators engaged in hazardous work such as high above the ground work and with the motor vehicles; 17. Subject can't complete the trial because of other reasons or unsuitable to participate in the trial considered by the researchers. Patients with acute coronary syndrome: 1. Cardiogenic shock at the time of randomization; 2. Refractory ventricular arrhythmias; 3. New York Heart Association class IV congestive heart failure; 4. Fibrin-specific fibrinolytic therapy less than 24 h before randomization; 5. Non-fibrin-specific fibrinolytic therapy less than 48 h before randomization; 6. Active internal bleeding or history of bleeding diathesis; 7. Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding; 8. Any of the following: a) History of hemorrhagic stroke; b) Intracranial neoplasm, arteriovenous malformation, or aneurysm; c) Ischemic stroke within 3 months prior to screening; 9. International normalized ratio known to be greater than 1.5 at the time of screening; 10. Platelet count of less than 100000/mm3 at the time of screening; 11. Anemia (hemoglobin <10 g/dL) at the time of screening; 12. Oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study; 13. Daily treatment with nonsteroidal antiinflammatory drugs or cyclooxygenase-2 inhibitors; 14. Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding; 15. Known severe hepatic dysfunction; 16. Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence; 17. Intolerance of or allergy to aspirin or ticagrelor; 18. May be unable to cooperate with protocol requirements and follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cardiovascular death;nonfatal myocardial infarction;nonfatal stroke;urgent target vessel revascularization;stent thrombosis;Platelet aggregation;VASP-P;Plasma concentration of ticagrelor;Plasma concentration of AR-C124910XX; | — |
Countries
China
Contacts
Public ContactTang Jie
Outcome results
None listed