Clinical trial NCT03037047: Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris
Official title: Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris: a Parallel, Double Blind, Randomized, Controlled, Multi-center Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Unstable Angina
Lead sponsor: Green Valley Group of China
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 320
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: symptom of angina pectoris
timeFrame: up to 14 days
Secondary outcomes:
measure: Seattle angina scale score
timeFrame: up to 28 days
measure: EQ-5D health scale
timeFrame: up to 28 days
measure: thrombolysis in myocardial infarction risk score
timeFrame: up to 28 days
measure: Incidence of cardiovascular and cerebrovascular events
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospita
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiaoying Li, doctor
role: STUDY_CHAIR
References:
citation: Cui H, Li XY, Gao XW, Lu X, Wu XP, Wang XF, Zheng XQ, Huang K, Liu F, Luo Z, Yuan HS, Sun G, Kong J, Du XH, Zheng J, Liu HY, Zhang WJ. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population. Chin J Integr Med. 2019 Oct;25(10):728-735. doi: 10.1007/s11655-019-2710-x. Epub 2019 Nov 28.