Unstable Angina
Conditions
Brief summary
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.
Detailed description
This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.
Interventions
DRUG0.9% Sodium Chloride Injection
Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
Sponsors
Green Valley Group of China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient in line with 1979 WHO diagnostic criteria for UA 2. Ages eligible for study: 60-85years (adult,senior) 3. Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly 4. Participates give written informed consent
Exclusion criteria
1. NSTE-ACS caused by non atherosclerotic disease 2. Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis) 3. Angina pectoris caused byanemia, methemoglobinemia and hypoxemia 4. Abnormal thyroid function 5. Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg) 6. Severe cardiopulmonary dysfunction 7. Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate \< 55),complete left bundle branch block 8. Combined liver and kidney and hematopoietic system and other serious diseases, liver function (ALT, AST) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2 9. Recent 4 weeks underwent surgery and bleeding tendency 10. Poor compliance 11. At the same time in other clinical researches 12. Allergic constitution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom of angina pectoris | up to 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Seattle angina scale score | up to 28 days |
| EQ-5D health scale | up to 28 days |
| thrombolysis in myocardial infarction risk score | up to 28 days |
| Incidence of cardiovascular and cerebrovascular events | up to 28 days |
Countries
China
Contacts
Primary ContactHongying Liu, doctor
Outcome results
None listed